[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Burkina Faso\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":722},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,49,85,119,143,169,193,215,231,250,308,336,369,402,424,447,471,498,523,551,579,606,635,656,690],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100559759","co-administration-of-calcium-and-multiple-micronutrient-supplements-for-maternal-and-newborn-hemoglobin-and-iron-status-100559759",false,"NCT06568315","Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status","Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status: A Randomized Non-inferiority Trial in Burkina Faso and Pakistan","CaMMS","Inclusion Criteria:\n\n* Burkina Faso: married or unmarried pregnant women aged ≥15 years\n* Pakistan: married pregnant women ≥18 years\n* Willing to receive all antenatal care at a study clinic\n* Willing to stop iron folic acid supplementation to receive the study intervention\n* Hb ≥70 g\u002FL\n* 6\\\u003C20 weeks of gestation based on fetal ultrasound\n\nExclusion Criteria:\n\n* Burkina Faso: \\\u003C15 years or unmarried pregnant women \\\u003C18 years without consent from parent \u002F guardian\n* Pakistan: pregnant women \\\u003C18 years.\n* Unwilling to receive antenatal care at a study clinic\n* Unwilling to stop iron folic acid supplementation to receive the study intervention\n* Hemoglobin \\\u003C 70 g\u002FL\n* \\\u003C6 weeks of gestation or ≥20 weeks of gestation\n* Non-viable or extrauterine pregnancy\n* Any contraindications to study supplements",true,"FEMALE","15 Years",{"count":22,"type":23},3200,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","The World Health Organization (WHO) currently recommends the pregnant women receive iron-containing supplements and, in settings where calcium intake is low, calcium supplements. Supplements are to be taken at two separate times of the day as calcium may interfere with iron absorption. The goal of this clinical trial is to learn whether taking daily calcium supplements and iron-containing multiple micronutrient supplements together, at the same time, has any negative impact on the hemoglobin or iron status of pregnant women or the woman's infants. Participants will be randomly assigned and counseled to either take the supplements together every morning or to take the multiple micronutrient supplement in the morning and the calcium supplement in the evening. Participants will visit the antenatal clinic monthly and be asked to provide a blood sample in early, mid, and late pregnancy. Researchers will also take blood samples from infants at the time of birth.",[29],"Anemia, Iron Deficiency",[31,32,33,34,35],"calcium","iron","supplementation","anemia","pregnancy","RECRUITING","2026-08-06",{"date":39,"type":40},"2026-08-10","ACTUAL",{"date":42,"type":40},"2025-08-25",{"date":44,"type":23},"2027-04",{"name":46,"class":47},"Johns Hopkins Bloomberg School of Public Health","OTHER",2,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100650556","assessing-vaccine-effectiveness-of-r21matrix-m-across-malaria-transmission-settings-avert-100650556","NCT07749911","Assessing Vaccine Effectiveness of R21\u002FMatrix-M Across Malaria Transmission Settings (AVERT)","Real-World Effectiveness of the R21\u002FMatrix-M Malaria Vaccine in Children in Burkina Faso and Uganda","AVERT","Inclusion Criteria:\n\n* Residence in an area where R21\u002FMatrix-M is implemented and within the catchment area of a selected study facility.\n* Younger than 5 years and eligibleto receive R21\u002FMatrix-M under the national vaccination schedule at rollout.\n* Meets the country definition of suspected malaria, generally axillary temperature of at least 37.5 degrees Celsius or a history of fever within the previous 24 hours, and is undergoing malaria testing.\n* Written informed consent provided by an adult caregiver aged 18 years or older.\n\nExclusion Criteria:\n\n* Caregiver is unable or unwilling to provide informed consent.\n* Severe non-malaria illness at presentation that would interfere with study participation.\n* Repeat presentation within the protocol-defined exclusion window after a previous enrollment: within 14 days after a microscopy-positive visit; or more than 7 but fewer than 14 days after a microscopy-negative visit. A microscopy-negative visit followed by a positive diagnosis within 7 days will be reclassified as positive rather than treated as a new enrollment.\n* Documented receipt of any RTS,S malaria vaccine dose.","ALL","5 Months","5 Years",{"count":61,"type":23},20000,"OBSERVATIONAL","The AVERT study is a prospective observational test-negative case control study evaluating the real-world effectiveness of the R21\u002FMatrix-M malaria vaccine among children younger than 5 years in Burkina Faso and Uganda. Children who seek outpatient care with suspected malaria and are eligible for the national R21\u002FMatrix-M vaccination program will be enrolled. Malaria infection will be determined by blood smear microscopy. Children with a positive microscopy result will be classified as cases and children with a negative result as controls. Vaccination history, including the number and timing of doses, will be obtained primarily from vaccination cards or other written records. Vaccine effectiveness will be estimated by comparing the odds of vaccination among cases and controls.",[65,66],"Malaria","PLASMODIUM FALCIPARUM MALARIA",[68,69,70,71,72,73,74,75],"R21\u002FMatrix-M","Malaria vaccine","Vaccine effectiveness","Test-negative design","Clinical malaria","Children","Burkina Faso","Uganda","2026-08-03",{"date":37,"type":40},{"date":79,"type":40},"2026-07-14",{"date":81,"type":23},"2027-08",{"name":83,"class":47},"Clinton Health Access Initiative Inc.",21,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":18,"sex":57,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":24,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"100649244","phase-1-challenge-trial-of-pfspz-larc2-vaccine-in-burkina-faso-100649244","NCT07730177","Challenge Trial of PfSPZ-LARC2 Vaccine in Burkina Faso","A Phase 1 Controlled Human Malaria Infection (CHMI) Study to Evaluate the Safety, Immunogenicity, and Efficacy of a Late Liver Stage-arresting, Replication-competent Plasmodium Falciparum Sporozoite Vaccine (Sanaria® PfSPZ-LARC2 Vaccine) Administered as a Single Dose to Malaria-exposed Adults in Burkina Faso","BFSPZL3","Inclusion Criteria:\n\n1. Healthy males and females, based on clinical and laboratory findings (note: an effort will be made to recruit roughly equal numbers of males and females, although a balanced sex ratio is not required)\n2. From 18 to 50 years of age\n3. Adults with a Body Mass Index (BMI) 18 to 30 Kg\u002Fm\\^2\n4. Residence in the study area for the duration of the study\n5. Agreement to release medical information and to inform the study doctor concerning contraindications for participation in the study\n6. Willingness to be attended to by a study clinician and take all necessary medications prescribed during study period\n7. Agreement to provide contact information of a third-party household member or close friend to study team\n8. Agreement not to participate in another clinical trial during the study period\n9. Agreement not to donate blood during the study period (until final clearance is completed)\n10. Able and willing to complete the study visit schedule over the study follow up period\n11. Willingness to undergo HIV, hepatitis B (HBV), hepatitis C (HCV), and sickle cell testing\n12. Able to demonstrate their understanding of the study by responding correctly to 18 out of 20 true\u002Ffalse statements (in a maximum of two repeat attempts for those who failed to pass in the first attempt)\n13. Signed written informed consent, in accordance with local practice\n14. Has not been treated with any antimalarial medication for at least two weeks before the initial clearance treatment.\n15. Female volunteers must be non-pregnant (as demonstrated by a negative urine pregnancy test) and provide consent \u002F assent of their willingness to take protocol-defined measures not to become pregnant during the study and safety follow-up period. Acceptable measures to not become pregnant include oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner, or sterile sexual partner during the entire study. Women with a history of surgical or chemical sterilization (e.g., tubal ligation, hysterectomy, other) must provide written documentation of the procedure from a health care provider.\n16. Ability to complete pre-vaccination drug clearance without significant untoward effects.\n\nExclusion Criteria:\n\n1. Unable to provide informed consent including inability to pass the test of understanding\n2. Receipt of a malaria vaccine in a prior clinical trial\n3. History of a splenectomy or sickle cell disease.\n4. History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache\n5. Current use of systemic immunosuppressant pharmacotherapy\n6. Receipt of a live vaccine within 4 weeks of first immunization or of 3 or more non-live vaccines within 2 weeks of first immunization\n7. Women who are breast-feeding, pregnant or planning to become pregnant during the study period\n8. Known allergy to artemether-lumefantrine (AL), dihydroartemisinin-piperaquine (DHA-P), or any component of the investigational products\n9. History of anaphylaxis or other life-threatening reaction to a vaccine\n10. Participation in any study involving investigational vaccine or drug within 4 weeks before enrollment that in the estimation of the site PI might adversely affect the individual's safety or the quality of data to be collected\n11. Evidence of increased cardiovascular disease risk; defined as \\>10% five-year risk by non-laboratory method\n12. Plan to participate in another investigational vaccine\u002Fdrug research during the study\n13. Plan for major surgery between enrollment until last study visit\n14. Use or planned use of any drug with anti-malarial activity that would precede or coincide with vaccination through to 56 days after controlled human malaria infection (CHMI)\n15. Anticipated use of medications known to cause drug interactions with DHA-P (antiarrhythmics, neuroleptics, macrolide antibiotics, fluoroquinolones, imidazole and triazole antifungal agents, quinine, halofantrine, pentamidine and saquinavir, certain non-sedating antihistamines, all of which can affect QT intervals ) or AL (the same list of drugs affecting QT intervals plus rifampin, carbamazepine, phenytoin, St. John's wort and antiretroviral drugs)\n16. Positive HIV, HBsAg or HCV serology\n17. Positive sickle cell trait or disease testing\n18. History of or evidence for other chronic disease conditions including cancer, diabetes, renal failure, hypertension, and tuberculosis\n19. History of arrythmias or cardiac disease, or an abnormal electrocardiogram, defined as one showing prolonged QT interval, pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions, but excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block; or other clinically significant abnormalities on the electrocardiogram\n20. Any clinically significant deviation from the normal range in biochemistry or hematology tests measured at screening and not resolving (grade 1 abnormalities are allowed)\n21. Any medical, psychiatric, social, behavioral or occupational condition or situation (including active alcohol or drug abuse affecting social function) that, in the judgment of the site PI, impairs the participant's ability to give informed consent, increases the risk to the participant of participation in the study, affects the ability of the participant to participate fully in the study, or might negatively impact the quality, consistency, integrity or interpretation of data derived from their participation in the study\n22. Inability to complete a course of malaria treatment before receipt of investigational product","18 Years","50 Years",{"count":96,"type":23},45,[98],"PHASE1","This is a randomized, double-blind, placebo-controlled, Phase 1 trial of Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) malaria vaccine (Sanaria® PfSPZ-LARC2 Vaccine) administered to healthy, malaria-exposed adults by direct venous inoculation (DVI) to determine safety, immunogenicity, and efficacy against controlled human malaria infection (CHMI).\n\nThe PfSPZ comprising PfSPZ-LARC2 Vaccine contain a double deletion of the genes encoding the Mei2 and LINUP proteins, both of which are required for transition from liver to blood stage malaria. As a result, mei2-\u002Flinup- parasites undergo developmental arrest in the late liver stages without releasing merozoites into the blood stream. No blood stage parasites are produced, either asexual or sexual, and the parasite life cycle does not progress.\n\nCHMI will be performed using PfSPZ Challenge (NF54), composed of PfSPZ that are genetically intact and fully infectious. Because PfSPZ-LARC2 vaccine is also based on the Pf strain NF54, CHMI using PfSPZ Challenge (NF54) is considered homologous to the vaccine. It will be performed 6 weeks after the single administration of PfSPZ-LARC2 Vaccine or normal saline placebo (with an option to shorten the interval to 4 weeks if logistical issues arise, such as a risk that CHMI follow-up will overlap with the rainy season).",[101],"Malaria (Plasmodium Falciparum)",[103,104,105,106],"PfSPZ Vaccine","PfSPZ-LARC2 Vaccine","PfSPZ Challenge","CHMI","NOT_YET_RECRUITING","2026-07-29",{"date":110,"type":40},"2026-07-31",{"date":112,"type":23},"2027-03",{"date":114,"type":23},"2028-01",{"name":116,"class":117},"Sanaria Inc.","INDUSTRY",1,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":18,"sex":57,"minAge":93,"maxAge":94,"enrollmentInfo":127,"targetDuration":4,"studyType":24,"phases":129,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":142,"locationsCount":118},"100622566","phase-2-field-trial-of-pfspz-larc2-vaccine-in-burkinabe-adults-100622566","NCT07385287","Field Trial of PfSPZ-LARC2 Vaccine in Burkinabe Adults","Randomized, Double-Blind, Placebo-Controlled Trial to Assess Safety, Immunogenicity, and Protective Efficacy Against Naturally Transmitted Plasmodium Falciparum Malaria of One and Two Dose Regimens of a Late Liver Stage-arresting, Replication-competent Plasmodium Falciparum Sporozoite Vaccine (Sanaria® PfSPZ-LARC2 Vaccine) in Healthy Malaria-Exposed Adults in Burkina Faso","BFSPZL2","Inclusion Criteria:\n\n1. Healthy males and females, based on clinical and laboratory findings\n2. From the age 18 to 50 years\n3. Adults with a Body Mass Index (BMI) 18 to 30 Kg\u002Fm2.\n4. Residence in the study area for the duration of the study.\n5. Agreement to release medical information and to inform the study doctor concerning contraindications for participation in the study.\n6. Willingness to be attended to by a study clinician and take all necessary medications prescribed during study period.\n7. Agreement to provide contact information of a third party household member or close friend to study team.\n8. Agreement not to participate in another clinical trial during the study period.\n9. Agreement not to donate blood during the study period (until final clearance is completed)\n10. Able and willing to complete the study visit schedule over the study follow up period.\n11. Willingness to undergo HIV, hepatitis B (HBV), hepatitis C (HCV), and sickle cell anemia tests.\n12. Volunteer participant can demonstrate their understanding of the study by responding correctly to 18 out of 20 true\u002Ffalse statements (in a maximum of two repeat attempts for those who failed to pass in the first attempt).\n13. Signed written informed consent, in accordance with local practice.\n14. Has not been treated with any antimalarial medication for at least two weeks prior to the initial clearance treatment.\n15. Female volunteers aged 18 years and above must be non-pregnant (as demonstrated by a negative urine pregnancy test), and provide consent \u002F assent of their willingness to take protocol-defined measures not to become pregnant during pre-treatment and immunization period and until 28 days after the second immunization. Acceptable measures to not become pregnant include oral or implanted contraceptives, IUD, abstinence, sterilization or sterile sexual partner. Women with a history of surgical or chemical sterilization (e.g., tubal ligation, hysterectomy, other) must provide written documentation of the procedure from a health care provider.\n16. Demonstration of the ability to complete pre-vaccination drug clearance without significant untoward effects.\n\nExclusion Criteria:\n\n1. Unable to provide informed consent including inability to pass the test of understanding.\n2. Receipt of a malaria vaccine in a prior clinical trial.\n3. History of a splenectomy or sickle cell disease.\n4. History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache.\n5. Current use of systemic immunosuppressant pharmacotherapy.\n6. Receipt of a live vaccine within 4 weeks of first immunization or of 3 or more non-live vaccines within 2 weeks of first immunization.\n7. Women who are breast-feeding, pregnant or planning to become pregnant during the study period.\n8. Known allergy to artemether-lumefantrine (AL), dihydroartemisinin-piperaquine (DHA-P), or any component of the investigational products.\n9. History of anaphylaxis or other life-threatening reaction to a vaccine.\n10. Participation in any study involving investigational vaccine or drug within 4 weeks prior to enrollment that in the estimation of the site PI might adversely affect the individual's safety or the quality of data to be collected.\n11. Evidence of increased cardiovascular disease risk; defined as \\>10% five-year risk by non-laboratory method (Gaziano, 2008).\n12. Plan to participate in another investigational vaccine\u002Fdrug research during the study.\n13. Plan for major surgery between enrollment until last study visit.\n14. Use or planned use of any drug with anti-malarial activity that is not specified by the protocol.\n15. Anticipated use of medications known to cause drug interactions with DHA-P (antiarrhythmics, neuroleptics, macrolide antibiotics, fluoroquinolones, imidazole and triazole antifungal agents, quinine, halofantrine, pentamidine and saquinavir, certain non-sedating antihistamines, all of which can affect QT intervals ) or AL (the same list of drugs affecting QT intervals plus rifampin, carbamazepine, phenytoin, St. John's wort and antiretroviral drugs).\n16. Positive HIV, HBsAg or HCV serology.\n17. History of or evidence for other chronic disease conditions including cancer, diabetes, renal failure, hypertension, tuberculosis, etc.\n18. History of arrythmias or cardiac disease, or an abnormal electrocardiogram, defined as one showing prolonged QT interval, pathologic Q waves and significant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions, but excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block; or other clinically significant abnormalities on the electrocardiogram.\n19. Any clinically significant deviation from the normal range in biochemistry or hematology tests measured at screening and not resolving (grade 1 abnormalities are allowed).\n20. Any medical, psychiatric, social, behavioral or occupational condition or situation (including active alcohol or drug abuse affecting social function) that, in the judgment of the site PI, impairs the participant's ability to give informed consent, increases the risk to the participant of participation in the study, affects the ability of the participant to participate fully in the study, or might negatively impact the quality, consistency, integrity or interpretation of data derived from their participation in the study.\n21. Inability to complete a course of malaria treatment prior to receipt of investigational product.",{"count":128,"type":23},180,[130],"PHASE2","This is a phase 2 clinical trial of a Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) vaccine (Sanaria® PfSPZ-LARC2 Vaccine) that will assess field efficacy in Africa.\n\nThe PfSPZ comprising PfSPZ-LARC2 Vaccine contain a double deletion of the genes encoding the Mei2 and LINUP proteins, both of which are required for transition from liver to blood stage malaria. As a result, mei2-\u002Flinup- parasites undergo developmental arrest in the late liver stages without releasing merozoites into the blood stream. No blood stage parasites are produced, either asexual or sexual, and the parasite life cycle does not progress. Because Pf parasites with the LARC phenotype replicate in the liver before disintegrating, they amplify and diversify parasite protein expression and are expected to be a potent immunogen to induce anti-malarial immunity, equaling or exceeding the potency and efficacy of the replication-competent chemo-attenuated Sanaria® PfSPZ-CVac (chloroquine) vaccine approach. Because the parasites are intrinsically attenuated, they are expected to be safe and well tolerated, similar to radiation-attenuated Sanaria® PfSPZ Vaccine, to the replication deficient, early arresting PfSPZ-GA1 Vaccine, and to the single-gene(mei2)-deleted GA2 (LARC1) parasites tested at the Leiden University Medical Center that provided 90% protection against CHMI after a single dose.\n\nThe active treatments to be assessed for efficacy are one immunization of 6.0x10\\^5 PfSPZ or two immunizations with 4.0x10\\^5 PfSPZ of PfSPZ-LARC2 Vaccine four weeks apart, timed so that the immunization of the one dose regimen coincides with the second immunization of the two dose regimen.\n\nThe alternative treatment is immunization with normal saline (placebo group), which is indistinguishable from the test article.\n\nThe primary variable of interest is whether and when trial participants develop Pf malaria parasitemia during surveillance. Malaria parasitemia will be detected by thick blood smear (TBS), which will be performed every two weeks starting two weeks after the second vaccination (to allow time for the vaccine to work) and extending to week 26 after the second vaccination (24-week surveillance period). Surveillance will continue for 40 weeks but the primary outcome will be determined at 24 weeks of surveillance so the data are comparable to other studies of PfSPZ vaccines.",[101],[134,135,103,104],"malaria","Plasmodium falciparum","2026-05-28",{"date":138,"type":40},"2026-06-01",{"date":140,"type":40},"2026-05-04",{"date":44,"type":23},{"name":116,"class":117},{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":18,"sex":57,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":24,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":48},"100583669","phase-2-infant-malaria-vaccine-schedule-optimization-100583669","NCT06879327","Infant Malaria Vaccine Schedule Optimization","A Phase 2b Multicenter Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of R21\u002FMatrix-M Malaria Vaccine in African Infants With Different Immunization Schedules","Inclusion Criteria:\n\n* Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent\u002Flegal guardian of the infant.\n* Infants must have been born full-term (at ≥37 weeks of gestation) and \\> 2500 grams at birth.\n* Immunization schedule Cohorts 1, 2, and 3: Male and female infants 42-49 days (inclusive) of age at time of enrollment.\n* Prior to group randomization, for infants in Cohort 1 randomization to receive vaccine dose 1 (Groups 1 and 2 of R21\u002FMM or placebo, respectively) will occur at 42-49 days of age. Infants in Cohorts 2 and 3 will not be randomized to R21\u002FMM or placebo; placebo will no longer be given. Rather infants in these cohorts will receive open-label R21\u002FMM according to the immunization schedule category to which they have been randomized. Infants in Cohort 2, will receive their open-label R21\u002FMM vaccine dose 1 (Group 3) at 2 months (56-63 days of age). Infants in Cohort 3, will receive their open-label R21\u002FMM vaccine dose 1 (Group 5) at 3 months (84-91 days of age).\n* The participant's parent\u002Fguardian must be willing to avoid travel, particularly in the 28 days after each study vaccination, must confirm willingness to contact the study team in the event of unexpected\u002Funavoidable travel and, for the safety cohort, must confirm availability for the home visits to be conducted by a field worker or nurse to collect solicited AEs over the 7 days (day of vaccination and 6 subsequent days) following each study vaccine.\n* The participant's parent\u002Fguardian must confirm willingness to bring their child to the study clinic \u002F local health care clinic, and capacity to contact the study team in the event the subject has any illnesses or other health concerns during the study.\n* Participants who the investigator believes that their parent\u002Fguardian can and will comply with the requirements of the protocol (e.g. return for follow-up visits) may be enrolled in the study.\n\nExclusion Criteria:\n\n• Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever). This does not include minor illnesses such as diarrhea, mild upper respiratory infection, without low-grade febrile illness, i.e. axillary temperature \\\u003C 37.5°C or tympanic temperature \\\u003C 38°C.\n\n(Note: In case of acute disease, participants may be re-assessed by a study physician for resolution of the condition and enrolled if eligible and still within the visit window).\n\n* Clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial.\n* At time of enrollment, any infant who has received any dose of the hexavalent\u002Fpentavalent vaccines, pneumococcal vaccine, rotavirus vaccine, IPV or has received more than one dose of oral polio virus or more than one dose of hepatitis B vaccine.\n* Weight-for-length\u002Fheight Z score of less than -3 or other clinical signs of malnutrition.\n* Infant with major congenital defects.\n* The infant has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g\u002FdL.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n* Any confirmed or suspected immunosuppressive or immunodeficient state (including HIV or asplenia) or known maternal HIV infection (no HIV testing will be routinely done by the study team).\n* Administration of immunoglobulins and\u002For any blood products\u002Fblood transfusion from birth to time of planned administration of the vaccine candidate.\n* Previous vaccination of participant or biological mother with a malaria vaccine.\n* Participation in another research study involving receipt of an investigational product or planned use during the study period.\n* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.","42 Days","49 Days",{"count":153,"type":23},964,[130],"The aim of this study is to identify an optimal infant vaccine schedule for a malaria vaccine which is better aligned with the timing of other vaccine interventions.",[157],"Malaria Vaccines",[135,159],"R21\u002FMatrix-M Malaria Vaccine","2026-05-13",{"date":162,"type":40},"2026-05-15",{"date":164,"type":40},"2025-05-30",{"date":166,"type":23},"2027-09-27",{"name":168,"class":47},"PATH",{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":18,"sex":57,"minAge":58,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":24,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":118},"100589729","phase-1-a-study-to-assess-the-experimental-malaria-vaccines-r78c-and-rh51-combined-with-r21matrix-m-a-multi-stage-malaria-vaccine-100589729","NCT06958198","A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21\u002FMatrix-M (a \"Multi-stage\" Malaria Vaccine)","A Phase Ib Age De-escalation, Open Label Study of the Safety and Immunogenicity of the Multi-stage Malaria Vaccine Candidate R21 + RH5.1 + R78C in Matrix-M™ in Adults Aged 18-35 Years and Children Aged 5-17 Months in Burkina Faso","VAC093","Inclusion Criteria:\n\nOnly participants who meet all the inclusion criteria will be enrolled into the trial:\n\n* Group 1: Healthy adult aged 18-35 years at the time of first study vaccination\n* Group 2-6: Healthy child aged 5-17 months at the time of first study vaccination\n* Group 1: Female participants must be non-pregnant (as demonstrated by a negative urine pregnancy .\n\ntest), and practice continuous effective contraception until three months after the final study vaccination\n\n* Participant or parent\u002Fguardian provides signed\u002Fthumb-printed informed consent\n* Participant (and parent\u002Fguardian for child participants) resident in the study area villages, and anticipated to be available for vaccination and the duration of follow-up -\n\nExclusion Criteria:\n\n* The participant may not enter the trial if ANY of the following apply:\n\n  * Clinically significant congenital abnormalities as judged by the PI or other delegated individual.\n  * Clinically significant skin disorder (psoriasis, contact dermatitis, etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual.\n  * History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).\n  * Children with weight-for-age Z score of less than -3 or other clinical signs of malnutrition.\n  * History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation.\n  * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n  * Sickle cell disease.\n  * Clinically significant laboratory abnormality at grade 2 or above as judged by the PI or other delegated individual.\n  * Administration of immunoglobulins and\u002For any blood products within the three months preceding the planned administration of the vaccine candidate.\n  * Receipt of any vaccine in the 14 days preceding enrolment, or planned receipt of any other vaccine within 28 days following each study vaccination.\n  * History of vaccination with any malaria vaccine.\n  * Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.\n  * Suspected or known current alcohol misuse.\n  * Suspected or known injecting drug use in the 5 years preceding enrolment.\n  * Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.\n  * Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.\n  * Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV IgG) or HIV. For children, any history of vertical exposure to HIV infection.\n  * Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (for corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg\u002Fkg\u002Fday; inhaled and topical steroids are allowed).\n  * Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.\n\nVaccination and re-vaccination exclusion criteria:\n\nThe following adverse events associated with vaccine immunisation constitute absolute contraindications to further administration of vaccine. If any of these events occur during the study, the participant must be withdrawn and followed until resolution of the event, as with any adverse event:\n\n* Anaphylactic reaction following administration of vaccine.\n* Pregnancy.\n\nThe following adverse events constitute contraindications to administration of vaccine at that point in time; if any one of these adverse events occurs at the time scheduled for vaccination, the participant may be vaccinated at a later date, or withdrawn at the discretion of the Investigator. The participant must be followed until resolution of the event as with any adverse event:\n\n* Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever or symptoms suggestive of possible COVID-19 disease). All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection without fever, i.e. axillary temperature \\\u003C 37.5°C.\n* Temperature of \\>37.5°C (99.5°F) at the time of vaccination.","35 Years",{"count":179,"type":23},56,[98],"This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and\u002For R78C in Matrix-M in adults aged 18-35 years and children aged 5-17 months in Burkina Faso.",[183],"Malaria,Falciparum","2026-03-09",{"date":186,"type":40},"2026-03-11",{"date":188,"type":40},"2025-09-15",{"date":190,"type":23},"2026-10",{"name":192,"class":47},"University of Oxford",{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":57,"minAge":4,"maxAge":93,"enrollmentInfo":200,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":214},"100395158","therapeutic-recommendations-for-the-treatment-of-children-with-a-retinoblastoma-100395158","NCT04425434","Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma","GFARB12019","Inclusion Criteria:\n\n* Unilateral intraocular Retinoblastoma (RB)\n* Unilateral extraocular intraorbital (RB)\n* Bilateral intraocular (RB)\n* bilateral intraocular (RB) on one side and extraocular but intraorbital on the other side.\n\nExclusion Criteria:\n\n* Externalized tumor mass\n* massive extension to optic nerve up to optical channeltumor\n* intracranial extension leptomeninges\n* cerebral parenchyma\n* extension to regional lymph nodes and\u002For remote metastases.\n* cerebrospinal fluid involvement.\n* Trilateral RB\n* Incapacity to followed the whole treatement.",{"count":201,"type":23},3000,"As the survival of children with retinoblastoma in high income countries is higher than 95% including the bilateral forms this study hopes to improve the outcome in low income countries in Africa by improving early diagnosis and early implementation of this protocol of therapeutic recommendations for treatment.",[204],"Retinoblastoma","2026-02-27",{"date":207,"type":40},"2026-03-02",{"date":209,"type":40},"2020-11-01",{"date":211,"type":23},"2030-12-31",{"name":213,"class":47},"French Africa Pediatric Oncology Group",7,{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":57,"minAge":4,"maxAge":93,"enrollmentInfo":222,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":229,"leadSponsor":230,"locationsCount":214},"100395157","recommendations-for-the-treatment-of-children-with-burkitts-lymphoma-100395157","NCT04425421","Recommendations for the Treatment of Children With Burkitt's Lymphoma","GFALMB2019","Inclusion Criteria:\n\nClinical diagnosis of Burkitt's Lymphoma: all location. Diagnosis by cytology or histology. Not possible to follow all the treatment.\n\n\\-\n\nExclusion Criteria:\n\nNot a B Cell tumor. Child has been previously treated. Child has also another illness which would render the treatment incompatible. Parents refusal.",{"count":223,"type":23},1000,"This is the 4th LMB study by the French African Pediatric Oncology Group (GFAOP). The study hopes to be able to evaluate children earlier with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for the stage IV disease.",[226],"Burkitt Lymphoma",{"date":207,"type":40},{"date":209,"type":40},{"date":211,"type":23},{"name":213,"class":47},{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":57,"minAge":239,"maxAge":93,"enrollmentInfo":240,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":214},"100395008","therapeutic-recommendations-for-nephroblastoma-100395008","NCT04423484","Therapeutic Recommendations for Nephroblastoma","Therapeutic Recommendations for the Treatment of Children With Nephroblastoma in Africa.","GFANEPHRO20","Inclusion Criteria:\n\nUnilateral Nephroblastoma Tumor Not previously treated The general health of the child will permit treatment.\n\n.\n\nExclusion Criteria:\n\nBilateral Nephroblastoma tumor Previously treated Disease too advanced Doubt concerning the diagnosis Treatment Refusal","6 Months",{"count":223,"type":23},"The study is based on results form 2 previous studies carried out by the GFAOP. The aim of this study is to evaluate the capacity of units to follow the recommendations in the protocol.",[243],"Nephroblastoma",{"date":207,"type":40},{"date":246,"type":40},"2020-07-01",{"date":248,"type":23},"2030-12-30",{"name":213,"class":47},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":18,"sex":57,"minAge":93,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":24,"phases":259,"briefSummary":261,"conditions":262,"keywords":288,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":307},"100560653","assessing-the-effects-of-cool-roofs-on-indoor-environments-and-health-100560653","NCT06579950","Assessing the Effects of Cool Roofs on Indoor Environments and Health","The Effects of Cool Roofs on Health, Environmental, and Economic Outcomes: a Global Multi-center Cluster-randomized Controlled Trial","REFLECT","Inclusion Criteria:\n\n* Permanent household resident.\n\nExclusion Criteria:\n\n* Roof damage, inaccessible or instability of roof adversely affecting cool roof coating application.\n* Participant unable to provide written\u002Fverbal informed consent.",{"count":22,"type":23},[260],"NA","Ambient air temperatures in Asian, Latin American, African, and Pacific climate hotspots have broken record highs in 2024, driven by man-made climate change. Solutions are needed to reduce heat exposure in communities. Sunlight-reflecting cool roof coatings passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions globally - for example in informal settlements, slums, and low-socioeconomic households - are especially vulnerable to increased indoor heat exposure.\n\nHeat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are being experienced in communities least able to adapt to heat exposure. By reducing indoor temperatures, cool roof use can promote physical, mental and social wellbeing in occupants.\n\nThe long-term research goal is to identify viable passive housing adaptation technologies with proven health and environmental benefits to reduce the burden of heat stress in communities affected by heat globally. To meet this goal, the investigators will conduct a cluster-randomized controlled trial to establish the effects of cool roof use on health, indoor environment and economic outcomes in five urban climate hotspots: Ouagadougou, Burkina Faso; Colima, Mexico; Ahmedabad, India; Niue; and Tavua, Fiji.",[263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287],"Resting Heart Rate","Blood Glucose Control","Depression","Heat-related Symptoms","Physician Diagnosed Heat-related Illnesses","Food Insecurity","Diet Quality","Health-related Quality of Life","Indoor Thermal Comfort","Coping Ability","Life Satisfaction","Healthcare Provider Utilization","Hospitalization","Systolic Blood Pressure","Diastolic Blood Pressure","Inner Ear Canal Temperature","Dehydration","Sleep Quality","Cognition","Productivity","Aggression","Indoor Air Temperature","Indoor Relative Humidity","Indoor Heat Index","Household Energy Expenditure",[289,290,291,292,293,265,294,295,296,297,298],"Hot Temperature","Humidity","Housing","Heart rate","Cardiovascular","Mental health","Blood glucose","Diabetes","Cool roof","Heat Stress","2026-02-25",{"date":205,"type":40},{"date":302,"type":40},"2024-09-04",{"date":304,"type":23},"2027-09-30",{"name":306,"class":47},"Aditi Bunker",5,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":18,"sex":57,"minAge":314,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":335},"100620268","frailty-geriatric-syndromes-and-care-pathways-of-older-adults-living-with-hiv-in-west-africa-100620268","NCT07355413","Frailty, Geriatric Syndromes and Care Pathways of Older Adults Living With HIV in West Africa","Inclusion Criteria:\n\n* HIV+ Group\n\n  * Person 60 years of age and older\n  * Infected with HIV-1 and\u002For 2\n  * Able to move around the data collection site\n  * Having given free and informed consent\n* HIV- Group\n\n  * Person 60 years of age and older\n  * HIV-uninfected\n  * Able to move around the data collection site\n  * Having given free and informed consent\n\nExclusion Criteria:\n\nPerson deprived of liberty (guardianship, curatorship, judicial safeguard) Karnofsky Index 50≤50% Hospitalized\n\n\\-","60 Years",{"count":316,"type":23},600,"With currently available antiretroviral therapy, people living with HIV (PLWHIV) are living longer. This exposure to HIV and combination antiretroviral therapy may accelerate the aging of this population, thus increasing the prevalence of premature frailty.\n\nThere are few data on the prevalence of frailty and geriatric syndromes among older people living with HIV (OpHIV) in sub-Saharan Africa (SSA) and the screening and diagnostic tools to identify them.\n\nThe initiation contract financed by the ANRS-MIE in 2021 whose objective was to 1) carry out an inventory and evaluate the feasibility of a project for monitoring OpHIV in Burkina-Faso in Côte d'Ivoire and Togo and 2) to select the collection tools adapted to the description of geriatric syndromes in these elderly people has allowed to highlight the following (i) The collection of data on geriatric conditions and syndromes is almost non-existent in the daily care and management practice (ii) there is a significant proportion (10,6%) of PLWHIV aged 60 years and over in the active files of the PLWHIV care centers that participated in the survey (iii) Adapted screening tools have been selected and will allow documentation of the above-mentioned syndromes. This research project, which follows on from this initiation contract, will therefore make it possible to obtain data from the geriatric evaluation, to identify the specificities of PLWHIV by comparing them to a population not infected with HIV and to propose geriatric management adapted to PLWHIV. Its innovative nature also lies in its mixed approach combining quantitative and qualitative methods, which will make it possible to document the needs and resources for the care of PLWHIV in a global and holistic manner.\n\n600 participants, aged 60 years and over (300 living with HIV and 300 not living with HIV), in three West African countries (Burkina Faso, Côte d'Ivoire, Togo) will be included in this study whose primary objective is to compare the prevalence of frailty among people aged 60 years and over (PA60) between HIV-infected and non-HIV-infected; the secondary objective is to estimate the prevalence of frailty among PA60 according to HIV status. A population-based matching will be performed on sex and age class (threshold 70 years), during the recruitment of HIV- PA60.\n\nThis will be a mixed study combining:\n\n* A \"clinical\" component comprising a stratified, comparative, international, multicenter cross-sectional study;\n* A \"health systems strengthening\" component combining a quantitative cross-sectional survey and a qualitative survey;\n* A qualitative socio-anthropological component including individual interviews and focus groups with people living with HIV60, their families and caregivers.\n\nThe 3 components will be conducted with a time lag between the different components due to the overlapping constitution of the source populations.\n\nMost research on aging with HIV in the context of SSA has been very clinically focused (e.g., frailty or cognitive impairment). This research will provide a more comprehensive approach that takes into account the different levels of factors influencing health (individual, health system, social environment).",[319],"Older Adults",[321,322,323,324],"HIV","Frailty","Geriatric syndromes","Care pathways","2026-01-14",{"date":327,"type":40},"2026-01-21",{"date":329,"type":23},"2026-03",{"date":331,"type":23},"2029-03",{"name":333,"class":334},"ANRS, Emerging Infectious Diseases","OTHER_GOV",6,{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":19,"minAge":344,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":24,"phases":347,"briefSummary":348,"conditions":349,"keywords":353,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":368},"100590046","phase-3-safety-of-antimalarials-in-the-first-trimester-100590046","NCT06962319","Safety of Antimalarials in the FIRst trimEster","A Multicentre Open-label, Non-inferiority Adaptive Platform Randomised Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Antimalarials for the Treatment of Uncomplicated Malaria in the First Trimester of Pregnancy: Master Protocol","SAFIRE","Inclusion Criteria:\n\n* ≥2 weeks and \\\u003C14 weeks (13-6\u002F7 weeks inclusive) gestation from the last menstrual period (LMP) as assessed by echography\n* Microscopy confirmed P. falciparum mono or mixed infections, regardless of symptoms.\n* Emancipated minor and aged ≥16 years\n* Haemoglobin ≥ 7 g\u002FdL\n* Residence within the health facility catchment area\n* Willingness to adhere to study requirements and to deliver the baby at the local health facility\n* Willingness to adhere to study requirements and to deliver the baby at the local health facility\n\nExclusion Criteria:\n\n* Known allergy to any of the study drugs\n* History of known pregnancy complications or poor obstetric history, such as repeated miscarriages, stillbirths, or eclampsia\n* History or presence of major illnesses likely to influence pregnancy outcome\n* Known HIV positive\n* Any significant illness at the time of screening requiring hospitalisation, including severe malaria\n* Intent to move out of the study catchment area before delivery or planned delivery out of the catchment area\n* Recent (2 weeks) treatment with antimalarials or antimicrobials with antimalarial activity (chloroquine, AL, DP, PA, SPAQ, ASAQ, MQAS, azithromycin, clindamycin, tetracycline, quinolones, cotrimoxazole and SP)\n* Twin\u002Fmultiple pregnancy detected\n* Non-viable pregnancy confirmed by ultrasound or doppler\n* Known history or evidence of clinically significant cardiovascular disorders or family history of sudden death or congenital long QT syndrome or current co administration of other drugs that might contribute to a prolonged QTc interval or cause \"Torsades de Point\"\n* Chronic medical condition requiring frequent medications (e.g., TB, suspected hepatic lesions, liver disease, sickle cell disease, diabetes, epilepsy, asthma and hypertension)\n* Prior randomisation in this study during the current pregnancy","16 Years",{"count":346,"type":23},1510,[26],"The SAFIRE study aims to find effective treatments with acceptable safety for malaria in early pregnancy, a particularly sensitive time for the adverse consequences of malaria in pregnancy for both mother and baby. Currently, WHO recommends the antimalarial drug artemether-lumefantrine (AL) for the treatment of uncomplicated malaria in the first trimester of pregnancy. Other promising treatments are being rolled out in malaria-endemic countries for use in adults and children and data on current exposures in the first trimester are limited and insufficient to support a recommendation. This is due to the fact that pregnant women are often excluded from clinical trials to protect fetuses, unintentionally depriving them of newer, potentially better treatments. Instead, they often received older, less effective drugs. The International Council for Harmonisation (ICH E21) and stringent regulatory authorities (e.g. EMA, FDA and MHRA) now encourage pregnant women to be included in well-designed studies to ensure they can safely benefit from medical advances.\n\nThis study will compare AL with the newer antimalarial drugs that have shown no significant safety concerns in laboratory studies, accidental use during early pregnancy, or trials in later pregnancy stages. The main goal is to see if these new drugs work as well as AL in treating malaria and are safe for the mother, her pregnancy and the developing baby. The newer antimalarials being tested also offer additional benefits to pregnant women, such as preventing new malaria infections for longer after treatment than the current standard treatment (AL). Also, they can be taken just once a day instead of twice daily, like AL. A simpler dosing schedule could improve adherence to the study medication, meaning women are more likely to take the full course of treatment as prescribed. This, in turn, enhances its effectiveness in real-world settings. Future antimalarials to be tested will include those with improved resistance profiles, offering more effective options for combating drug-resistant strains.\n\nSAFIRE uses a special \"Bayesian Adaptive Platform Trial\" (APT) design. This open-ended approach allows researchers to add new interventions under the same protocol, leveraging the existing trial network with infrastructure. The use of a common protocol with innovative adaptive statistical design allows the trial to stop early if it becomes clear that the new drugs are unsafe.\n\nThis multi-centre trial will be conducted in several countries in Africa where malaria is very common. Women will be randomly assigned to receive either AL or one of the new treatments. Participants will be seen daily for 4 days, then weekly for 6 weeks to assess the response to treatment, and then monthly until delivery. Their health and outcomes will be closely monitored during and after pregnancy. Newborns will be followed for 6 months. An independent data safety and monitoring board (DSMB) will regularly monitor safety data as it accumulates. By finding more treatment options, this study could improve care for pregnant women with malaria and lead to better health for mothers and babies in areas where malaria is widespread. The results will help inform global health policies and potentially change how we treat malaria in early pregnancy.",[350,351,352],"Malaria, Pregnancy","Malaria, Antepartum","Malaria (Uncomplicated)",[65,354,355,356,357,358],"Pregnancy","First trimester","antimalaria","artemether-lumefantrine","Adaptive Platform Trial","2025-11-18",{"date":361,"type":40},"2025-11-19",{"date":363,"type":40},"2025-09-30",{"date":365,"type":23},"2029-08",{"name":367,"class":47},"Liverpool School of Tropical Medicine",3,{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":18,"sex":57,"minAge":239,"maxAge":377,"enrollmentInfo":378,"targetDuration":4,"studyType":24,"phases":380,"briefSummary":381,"conditions":382,"keywords":388,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":118},"100562162","mother-screening-for-relapse-using-mid-upper-arm-circumference-among-children-recovered-from-severe-acute-malnutrition-full-scale-trial-100562162","NCT06599580","Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition (Full Scale Trial)","Mother Screening for Relapse Using Mid-upper Arm Circumference Among Children Recovered From Severe Acute Malnutrition (MAMAN)","MAMAN","Inclusion Criteria:\n\n* Caregiver's aged 18 years old or older or a legal guardian or a relative aged 18 or older\n* Child aged 6-54 months\n* Child has recovered from an episode of severe acute malnutrition per Burkinabè national guidelines (weight-for-height ≥ -2 and\u002For mid-upper arm circumference ≥ 12.5 cm in the past month, with the criterion used for admissions corresponding to the original admission criteria)\n* Family is planning to stay in the study area for 6 months\n* Appropriate consent from the caregiver or guardian.\n\nExclusion Criteria:\n\n* Caregiver age under 18 years old, or legal guardian or relatives under 18 years old\n* Child age \\\u003C 6 months or \\> 54 months\n* Twins\u002Fmultiple births\n* Children with feeding issues\n* Did not recover from severe acute malnutrition in the past month\n* Family is planning to move out of the study area in the next 6 months\n* Caregiver or guardian refuses to provide consent","54 Months",{"count":379,"type":23},2400,[260],"A 1:1:1 individually randomized unmasked controlled trial is proposed in which caregivers will be trained to screen their children who have recovered from an episode of SAM (severe acute malnutrition) using MUAC (mid-upper arm circumference) tapes. One arm will include caregiver screening with a mid-upper arm circumference tape and usual monthly follow-up schedule for the first 3 months post enrollment and a final follow-up at 6 months. Another arm will include caregiver screening with a mid-upper arm circumference tape and a reduced follow-up schedule for one visit at 3 months and a final visit at 6 months. The third arm will adhere to the current standard of care, which is no caregiver training to conduct mid-upper arm circumference screenings and monthly clinic-based follow-up appointments for 3 months with a final visit at 6 months post enrollment. Children aged 6-54 months with a documented recovery from uncomplicated severe acute malnutrition that was managed in a participating outpatient nutritional program and their caregivers will be eligible for inclusion in the trial. Caregivers will be trained to screen their children weekly for 6 months following discharge from the nutritional program and will be counseled to bring their child back to the nutritional program should their mid-upper arm circumference value fall in the red zone of the mid-upper arm circumference tape (\\\u003C 11.5 cm). All children will be seen at 3 and 6 months for the primary outcome assessment. By conducting this study, our primary goal is to determine if training caregivers to screen their children for relapse to MAM (moderate acute malnutrition) or SAM (severe acute malnutrition) using mid-upper arm circumference tapes following recovery from SAM (severe acute malnutrition) will reduce the risk of relapse. An additional aim is to assess the level of acceptability of caregivers screening children for malnutrition using mid-upper arm circumference tapes from both a clinic and caregiver perspective.",[383,384,385,386,387],"Malnutrition, Child","Malnutrition, Infant","Malnutrition or Risk of Malnutrition","Hemoglobin Level Measurement","Anemia",[389,390,391,392],"MUAC (mid-upper arm circumference)","Caregiver screening","malnutrition","home based malnutrition screening","2025-11-17",{"date":395,"type":40},"2025-11-20",{"date":397,"type":40},"2025-03-20",{"date":399,"type":23},"2027-11",{"name":401,"class":47},"University of California, San Francisco",{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":19,"minAge":93,"maxAge":4,"enrollmentInfo":410,"targetDuration":4,"studyType":24,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":118},"100603305","phase-2-maternal-probiotic-intervention-to-improve-gut-health---trial-ii---burkina-faso-mpigh-ii-100603305","NCT07134790","Maternal Probiotic Intervention to Improve Gut Health - Trial II - Burkina Faso (MPIGH-II)","Ability of the Probiotic VE818 to Reduce Enteropathogen Colonization and Improve Environmental Enteropathy in Pregnant Women: A Proof-of-Concept and Phase II Randomized Placebo-Controlled Trial in Bangladesh, Pakistan, Zambia, and Burkina Faso.","MPIGH-II","All pregnant women in their first or early second trimester of pregnancy, residing in the icddr,b service area of Matlab, who meet the eligibility criteria decribed below.\n\nInclusion criteria\n\n1. Women aged 18 years or older in their first or early second trimester of pregnancy (13-17 weeks of gestational age \\[GA\\]), living in defined geographical areas of Bangladesh (Matlab), Pakistan, Zambia, and Burkina Faso, where it can be assumed that environmental enteropathy is prevalent\n\n   AND\n2. Presence of any 2 out of 11 selected bacterial pathogen targets (Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli, Enteropathogenic Escherichia coli, Enterotoxigenic Escherichia coli, Plesiomonas, Shigella\\_EIEC, Salmonella and Klebsiella pneumoniae in fecal samples measured by TAC-qPCR.\n\n   AND\n3. Presence of any of the following WASH conditions -\n\n1\\. use surface water, unimproved water, or limited water for drinking; OR 2. use surface water, unimproved water, or limited water for cooking; OR 3. use surface water, unimproved water, or limited water for washing utensils; OR 4. practice open defecation, use unimproved sanitation (toilet facility), or limited sanitation (toilet facility); OR 5. lack facility or have limited facility for handwashing\n\nExclusion criteria\n\nPotential participants will not be enrolled if they:\n\n1. have MUAC ≥30 cm\n2. are carrying more than one fetus (i.e., multiple pregnancy)\n3. have diarrhea, defined as the passage of three or more loose stools per 24 hours, or have had diarrhea in the preceding 14 days\n4. have fever or an active infection\n5. have taken antibiotics or probiotics in the preceding 14 days\n6. have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 14 days\n7. have severe anemia as determined using finger stick Hb \\\u003C 8 g\u002Fdl\n8. have a history of chronic digestive disease\n9. have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder)\n10. have known immunocompromised status (known history of HIV infection, autoimmune disease, diabetes mellitus, etc.)\n11. have known drug hypersensitivity\u002Fallergy\u002Fintolerance\n12. have chronic disease or any other illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy\n13. are medically disqualified: Any potential participant who is deemed medically unfit for trial enrollment by a non-study healthcare provider, due to the presence of severe or unstable health conditions that could compromise safety or interfere with the study outcomes, will be excluded from participation\n14. have a plan to observe fast any time during the intervention period\n15. have a plan to leave the study area within the follow-up period\n16. are participating in any other interventional trial\n17. belong to a household from which another woman is already enrolled in the study\n\nbut may be enrolled if\u002Fwhen these disqualifiers have expired.",{"count":411,"type":23},144,[130],"Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterized by altered gut permeability, infiltration of immune cells and changes in villous architecture and cell differentiation. EED is a major reason of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection. It is believed that EED is responsible for 40% of all childhood stunting.\n\nKnowledge gap: To date the focus of research on childhood stunting has been on the young child. It is increasingly appreciated, however, that stunting often begins in utero and the focus has shifted to women's health and pregnancy. Results from rural Bangladesh reveal poor gestational weight gain that ultimately leads to intrauterine growth restriction, low birth weight and ultimately stunting and wasting. Another study recently completed in slum settlements of Dhaka, Bangladesh demonstrated a high prevalence of EED among undernourished women. Intestinal histopathology was abnormal in more than 80% of women. We postulate that growth retardation in utero is a consequence of EED in the mother during pregnancy and lactation. This leads to systemic inflammation, which lead to disadvantageous partitioning of nutrients, and reduced nutrient availability.\n\nRelevance: This trial will explore the conceptual framework that a probiotic or live biotherapeutic product that can improve the composition of gut microbiota, can also displace enteropathogens and reduce biomarkers of intestinal inflammation to promote gut health. This will restore healthy microbial signaling to the host epithelium, ameliorate barrier function through secretion of mucus and antimicrobial factors, and improve nutrient availability.\n\nObjectives: The primary objective is to assess if administration of oral vancomycin followed by VE818 to pregnant women colonized with at least 2 out of 11 selected bacterial enteropathogens results in a significant change in the mean count of these organisms between the baseline and 2 weeks after completion of the intervention (Study Day 35d +2), compared to oral vancomycin followed by placebo.\n\nMethods: Pregnant women will be recruited in antenatal clinics and in the community in Matlab in Bangladesh, Bobo-Dioulasso in Burkina Faso, Matiari in Pakistan, and Lusaka in Zambia. Study population will be women aged 18 years or older in the first trimester or early second trimester of pregnancy. Study procedures will be explained in detail and written consent will be taken before enrollment. Those women who give consent to participation will undergo a screening process which will check if any exclusion criteria are fulfilled. After consent and screening they will be randomized into either of the three arms: intervention arm (oral vancomycin followed by VE818), placebo-control arm (oral vancomycin followed by placebo), or observation-only arm. The allocation sequence will be generated by the trial statistician using a code with block permutation. The participant will remain free to withdraw at any time from the trial without giving reasons and without prejudicing her further treatment. Biological samples, including blood, saliva, urine, stool, vaginal swab, and intestinal luminal contents through CapScan. CapScan is a non-invasive device (capsule) that collects gastrointestinal samples along the gastrointestinal tract following ingestion and passes into stool.\n\nOutcome measures\u002Fvariables: The primary endpoint is the change in the mean count in the number of 11 selected fecal bacterial pathogen groups present between baseline and 2 weeks after completion of the 14-day course with Placebo or VE818 (Study arms 2 and 3), which corresponds to 35th day, +2 from the first dose of oral vancomycin.\n\nThe 11 enteropathogen targets will be detected by customized real-time quantitative PCR-based TaqMan Array Cards (TAC-qPCR) and include the following organisms: Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli (E. coli), Enteropathogenic E. coli, Enterotoxigenic E. coli, Plesiomonas, Shigella\\_Enteroinvasive E. coli (EIEC), Salmonella and Klebsiella pneumoniae.",[415],"Environmental Enteric Dysfunction (EED)","2025-11-14",{"date":393,"type":40},{"date":419,"type":40},"2025-07-30",{"date":421,"type":23},"2027-06-07",{"name":423,"class":47},"University Ghent",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":57,"minAge":239,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":24,"phases":434,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":118},"100516913","phase-4-azithromycin-as-adjunctive-treatment-for-uncomplicated-severe-acute-malnutrition-100516913","NCT06010719","Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition","Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition: the AMOUR Trial","AMOUR","Children with uncomplicated SAM per Burkina Faso's national guidelines who present to an eligible enrollment site during the study period and meet all of the eligibility criteria below will be considered for enrollment:\n\nInclusion criteria:\n\n* Age 6-59 months\n* WHZ\\\u003C-3 SD or MUAC\\\u003C115 mm\n* Primary residence within a catchment area of an enrollment site\n* Available for full 8-week study (primary endpoint)\n* Not admitted to a nutritional program for SAM treatment in the previous 2 weeks\n* No edema\n* No antibiotic use in the past 7 days\n* No clinical complications requiring antibiotic or inpatient treatment\\*\\*\n* No congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip\u002Fpalate, etc)\n* No known allergies to macrolides\u002Fazalides or amoxicillin\u002Fpenicillin\n* Sufficient appetite according to a feeding test with RUTF\n* Written informed consent from at least one parent or guardian\n\nExclusion criteria:\n\n* Age less than 6 month or more than 59 months\n* WHZ\\>-3 SD or MUAC\\>115 mm\n* Primary residence is not within a catchment area of an enrollment site\n* Not Available for full 8-week study (primary endpoint)\n* Admitted to a nutritional program for SAM treatment in the previous 2 weeks\n* Edema\n* Antibiotic use in the past 7 days\n* Clinical complications requiring antibiotic or inpatient treatment\\*\\*\n* Congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip\u002Fpalate, etc)\n* Known allergies to macrolides\u002Fazalides or amoxicillin\u002Fpenicillin\n* No Sufficient appetite according to a feeding test with RUTF\n* No Written informed consent from at least one parent or guardian\n\n  * Per Burkinabé guidelines, children any of the following conditions will not be eligible for the trial and will be referred to an inpatient facility: MUAC \\\u003C115 mm with complications; MUAC \\\u003C115 mm plus edema; bipedal pitting edema; anorexia or no appetite for RUTF; diarrhea and dehydration; unable to ingest anything without vomiting; severe pneumonia; open cutaneous lesions; hypothermia (35\\*C); fever (38.5\\*C); paleness suggesting severe anemia; hypoglycemia; very weak, lethargic, or unconscious; convulsions; signs of vitamin A deficiency; or a condition requiring IV infusion or an NG tube.","59 Months",{"count":201,"type":23},[435],"PHASE4","Amoxicillin is recommended by the World Health Organization (WHO) as adjunctive therapy for the treatment of uncomplicated severe acute malnutrition (SAM). Because children with uncomplicated SAM may have asymptomatic infection due to immune suppression, presumptive treatment with a broad-spectrum antibiotic may be beneficial by clearing any existing infection and improving outcomes. Two randomized placebo-controlled randomized trials have evaluated amoxicillin for uncomplicated SAM and have found conflicting results. These results may indicate either that antibiotics are not helpful for the management of uncomplicated SAM, or that a better antibiotic is needed. Recently, the investigators demonstrated that biannual mass azithromycin distribution as a single oral dose reduces all-cause child mortality in sub-Saharan Africa. Children with uncomplicated SAM, who have an elevated risk of mortality relative to their well-nourished peers, may particularly benefit from presumptive azithromycin treatment. Our pilot data demonstrated feasibility in rapid enrollment of children with uncomplicated SAM in our study area, and showed no significant difference between azithromycin and amoxicillin, demonstrating equipoise for a full-scale trial. Here, the investigators propose an individually randomized trial in which children will be randomized to a) azithromycin, b) amoxicillin, or c) placebo, and evaluated for differences in weight gain, nutritional recovery, and the gut microbiome. The results of this study will strengthen the evidence base for policy related to the use of antibiotics as part of the management of uncomplicated SAM, including additional evidence of amoxicillin versus placebo as well as evaluation of an antibiotic class that has not been considered for uncomplicated SAM, which may lead to changes in guidelines for treatment.",[383,438],"Severe Acute Malnutrition","2025-10-13",{"date":441,"type":40},"2025-10-15",{"date":443,"type":40},"2024-10-23",{"date":445,"type":23},"2028-12-29",{"name":401,"class":47},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":57,"minAge":455,"maxAge":93,"enrollmentInfo":456,"targetDuration":458,"studyType":62,"phases":4,"briefSummary":459,"conditions":460,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":470},"100347437","hospital-based-registry-of-childhood-cancer-in-pediatric-oncology-units-in-french-speaking-africa-100347437","NCT03803735","Hospital Based Registry of Childhood Cancer in Pediatric Oncology Units in French Speaking Africa","French African Pediatric Oncology Registry","RFAOP","Inclusion Criteria:\n\n1. Any child presenting at any one of the participating units for treatment\n2. Any child with any type of cancer\n3. Any child or adolescent less than 18 years of age.\n\nExclusion Criteria:\n\n1. No cancer found\n2. Age greater than 18 years -","1 Day",{"count":457,"type":23},10000,"12 Months","The ultimate aim of this registry is to collect precise information concerning the children coming to oncology units working with the French African Oncology Group. This data will help to plan and provide correct pediatric oncology treatment and care for this population.\n\nCollecting the data will give much needed information on numbers, stage, treatment and outcome. The register will give data for local and national health authorities in planning pediatric cancer programs.",[461],"Pediatric Cancer","2025-09-29",{"date":464,"type":40},"2025-10-03",{"date":466,"type":40},"2016-01-01",{"date":468,"type":23},"2030-12",{"name":213,"class":47},14,{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":57,"minAge":455,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":24,"phases":481,"briefSummary":482,"conditions":483,"keywords":487,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":118},"100497933","phase-4-vitality-in-infants-via-azithromycin-for-neonates-trial-100497933","NCT05763693","Vitality in Infants Via Azithromycin for Neonates Trial","VIVANT","Inclusion Criteria:\n\n* Aged 1-27 days old\n* Birthweight \\\u003C 2500 g and\u002For weight-for-height Z score \\\u003C- 2 standard deviations at enrollment\n* Weigh at least 1500 g at time of enrollment\n* Able to feed orally\n* Family intends to stay in the study area for at least 6 months\n* Written informed consent from at least one caregiver\n* Afebrile\n* Caregiver at least 18 years old\n* No known allergy to macrolides\n* No hepatic failure manifested by neonatal jaundice\n* Not currently an inpatient at the clinic\n* Not being transferred to a hospital for clinical complications\n\nExclusion Criteria:\n\n* Birthweight \\> 2500 g\n* Weigh less than 1500 g at time of enrollment\n* Unable to feed orally\n* Family planning to move within 6 months\n* Mother\u002F caregiver not willing to participate\n* Allergic to macrolides\n* Hepatic failure manifested by neonatal jaundice\n* Currently being seen as an inpatient at the clinic\n* Currently being transferred to a hospital for clinical complications","27 Days",{"count":480,"type":23},4000,[435],"Nearly half of child deaths occur during the neonatal period, and 80% of those occur in babies with low birthweight. Although tremendous progress has been made towards reducing under-five mortality globally, declines in neonatal mortality lag behind those observed in older children. Low birthweight babies are at increased risk of poor outcomes compared to those who are term-appropriate for gestational age, including mortality, stunting, and growth failure. Recent evidence has demonstrated that the incidence of wasting and linear growth failure is highest between birth and 3 months of age, substantially earlier than previously thought. Interventions are urgently needed to improve outcomes in low birthweight babies; however, these interventions must not interfere with breastfeeding and thus some well-established interventions used to treat or prevent malnutrition in older children cannot be considered. The investigators recently demonstrated that biannual mass azithromycin distribution reduces all-cause childhood mortality by approximately 25% in infants aged 1-5 months, with stronger effects seen in underweight infants. This study did not include neonates due to the risk of infantile hypertrophic pyloric stenosis (IHPS) that has been hypothesized to be associated with macrolide use during early infancy. However, our study team documented only a single case of IHPS among 21,833 neonates enrolled in a trial of azithromycin versus placebo administered to neonates aged 8-27 days for prevention of infant mortality, documenting no major risk of IHPS associated with azithromycin. Here, the investigators propose an individually randomized trial where participants will receive a single oral dose of azithromycin (administered either during the neontal period or 21 days after enrollment), two does of oral azithromycin spaced 21 days apart, or two doses of placebo to evalute if azithromycin improves nutritional outcome and reduces infectious burden among neonates aged 1-27 days who are either low birthweight (\\\u003C2500 g at birth) or underweight (weight-for-age Z-score \\\u003C -2 at enrollment). The primary outcome will be weight-for-age Z-score at 6 months of age compared between arms. The investigators anticipate that the results of this study will provide definitive evidence on azithromycin as an early intervention for low birthweight\u002Funderweight neonates, who are at the highest risk of adverse outcomes.",[484,485,486],"Neonatal Death","Infectious Disease","Nutritional Deficiency",[488,489],"Low birth weight","underweight neonates","2025-08-28",{"date":492,"type":40},"2025-08-29",{"date":494,"type":23},"2026-04",{"date":496,"type":23},"2030-04",{"name":401,"class":47},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":18,"sex":57,"minAge":58,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":307},"100593700","an-observational-study-to-assess-effectiveness-and-safety-of-the-r21matrix-m-malaria-vaccine-100593700","NCT07009847","An Observational Study to Assess Effectiveness and Safety of The R21\u002FMatrix-M Malaria Vaccine","A Case Control Study to Assess Effectiveness and Safety of The R21\u002FMatrix-M Malaria Vaccine","Inclusion Criteria:\n\nFor Cases- A male or female child eligible to have received R21\u002FMatrix-M Vaccine based on age. 2 Parent\u002Flegal guardian\u002F caregiver of the child willing to provide the written informed consent for their child's participation in the study.\n\n3 Parent\u002Flegal guardian\u002F caregiver willing to comply with the study requirements and share or allow access to the data regarding the vaccination status and medical records with the study personnel.\n\n4 Resident of the R21\u002FMatrix-M vaccine implementation area and brought to the study hospital \u002Fclinic or sub-site with clinical complaints. 5 Child meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).\n\nFor Controls- A male or female child eligible to have received R21\u002FMatrix-M Vaccine based on age. The matched control should have a date of birth within 60 days of that of the case.\n\n2\\. Parent\u002Flegal guardian\u002F caregiver of the child willing to provide the informed consent for their child's participation in the study.\n\n3\\. Parent\u002F legal guardian\u002F caregiver willing to comply with the study requirements and share or allow access to the data regarding the vaccination status and medical records with the study personnel 4. Resident of the R21\u002FMatrix-M vaccine implementation area and who would have sought treatment at the same hospital if they had developed symptoms. Resident will be defined as child and\u002For child's parents\u002F guardian\u002Fcaregiver eating and sleeping in a household in the location for most days of the week from past 6 months. The matched control should be residing in the same neighborhood as the respective case, but not from the same household.\n\nExclusion Criteria:\n\nFor Cases-\n\n1. Parent\u002Flegal guardian\u002F caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.\n2. Child not meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).\n3. Received one or more doses of RTS,S\u002FAS01 vaccine in the past.\n\nFor Controls-\n\n1. Parent\u002Flegal guardian\u002F caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.\n2. Child meeting any of the case definitions (Severe Malaria, Clinical Malaria).\n3. Child having history suggestive of clinical malaria in past 30 days (applicable for clinical malaria and severe malaria case-control studies only).\n4. Received one or more doses of RTS,S\u002FAS01 vaccine\u002Fs in the past.",{"count":506,"type":23},2308,"This is an observational case-control study to assess the effectiveness of the R21\u002FMatrix-M vaccine against severe malaria, clinical malaria (in high transmission perennial areas), and to assess if the R21 vaccine recipients are at an increased risk of deaths (all-cause). Clinical malaria, severe malaria and death (all-cause) cases will be enrolled in study. For each case (severe or death) 4 controls matched for age and neighborhood will be enrolled whereas for clinical malaria case, 1 matched control will be enrolled.\n\n1. Proportion of vaccinated and unvaccinated children amongst Severe Malaria Cases caused by P. falciparum.\n2. Proportion of vaccinated and unvaccinated children amongst Clinical Malaria Cases in high-transmission perennial areas caused by P. falciparum.\n3. Proportion of vaccinated and unvaccinated children in cases of death (all cause)\n4. Exploratory effectiveness endpoint: Proportion of vaccinated and unvaccinated children in the hospitalized clinical and severe malaria cases.",[183,509],"Morality",[511,512,513],"clinical malaria","severe malaria","death (all cause)","2025-08-12",{"date":516,"type":40},"2025-08-13",{"date":518,"type":40},"2025-06-16",{"date":520,"type":23},"2026-12-31",{"name":522,"class":117},"Serum Institute of India Pvt. Ltd.",{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":18,"sex":57,"minAge":530,"maxAge":432,"enrollmentInfo":531,"targetDuration":4,"studyType":24,"phases":533,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":48},"100582197","phase-4-integrating-malaria-vaccine-with-seasonal-malaria-chemoprevention-in-west-africa-100582197","NCT06860178","Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa","IMVACS","Inclusion criteria:\n\nControl arms :\n\n* Children aged 5-36 months in Burkina Faso and Mali at the time of first study vaccination;\n* Resident in the catchment area of a health centre assigned to the control arm;\n* Willingness to comply with the study procedures;\n* Written informed consent from Parent\u002FGuardian.\n\nIntervention arms :\n\n* Children aged 3-59 months at the time of first study vaccination;\n* Resident in the catchment area of a health centre assigned to the intervention arm;\n* Willingness to comply with the study procedures;\n* Written informed consent from Parent\u002FGuardian.\n\nExclusion Criteria:\n\n1. History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines;\n2. Any history of anaphylaxis in relation to vaccination;\n3. Known chronic illness;\n4. Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial;\n5. History of vaccination with another malaria vaccine. -","3 Months",{"count":532,"type":23},40000,[435],"This is a multi-site, multi-disciplinary, Phase-4 two-arm cluster-randomised non-inferiority trial in Burkina Faso and Mali to evaluate the effectiveness and real-life impact of a novel integrated delivery strategy of the R21 malaria vaccine alongside SMC among children in areas with highly seasonal malaria transmission. In this study, a cluster is defined as the catchment area of a health centre. Clusters will be randomised to receive either year-round age-based routine EPI vaccination for children aged 5-36 months (\"Routine EPI Vaccination\") in Burkina Faso or an annual campaign of the 3-dose primary series in children aged 5-36 months prior to the malaria season and SMC delivery (''Routine Pre-SMC vaccination'') in Mali versus an annual campaign of the 3-dose primary series aligned with SMC distribution in children aged 3-59 months (\"Integrated SMC Vaccination\") in each country. Effectiveness will be assessed in terms of clinical malaria, vaccine coverage, acceptability, feasibility, and cost-effectiveness.\n\nMalaria incidence will be determined using routine surveillance activities for clinical malaria detection and reporting in each country. Cross-sectional surveys will be conducted to determine the prevalence of parasitaemia in the communities. In addition, the acceptability, feasibility, coverage and cost-effectiveness of the different delivery systems of R21\u002FMatrix-M will be assessed.",[536],"Malaria Vaccine",[134,538,539,540,541],"CPS","pediatric","vaccine","R21","2025-08-05",{"date":544,"type":40},"2025-08-08",{"date":546,"type":40},"2025-06-10",{"date":548,"type":23},"2027-12",{"name":550,"class":47},"Epicentre",{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":57,"minAge":559,"maxAge":560,"enrollmentInfo":561,"targetDuration":4,"studyType":24,"phases":563,"briefSummary":564,"conditions":565,"keywords":567,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":578},"100496929","phase-2-platform-study-to-evaluate-the-efficacy-and-safety-of-anti-malarial-agents-in-patients-with-uncomplicated-plasmodium-falciparum-malaria-100496929","NCT05750628","Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria","A Multi-part, Multi-center PLATform Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Anti-malarial Agents Administered as Monotherapy and\u002For Combination Therapy IN Patients With Uncomplicated Plasmodium Falciparum Malaria","PLATINUM","Inclusion Criteria:\n\n1. Male and female patients ≥18 years of age for Part A, ≥12 years of age for Part B and 2 to \\\u003C12 years of age for Part C at screening.\n2. Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150,000 asexual parasite count\u002Fμl of blood for P. falciparum for Part A and between 1,000 to 150,000 asexual parasite count\u002Fμl of blood for Parts B and C.\n3. Patients in Part A must weigh between 40 kg and 90 kg. Patients in Part B must weigh between 35 kg and 90 kg at screening. Patients in Part C must weigh at least 10 kg at screening.\n4. Axillary temperature ≥ 37.5ºC or oral\u002Ftympanic\u002Frectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours.\n\nExclusion Criteria:\n\n1. Patients with signs and symptoms of severe\u002Fcomplicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening\n2. Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level \\\u003C 8 g\u002FdL), or known chronic underlying disease such as sickle cell disease at screening\n3. Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening:\n\n   * AST\u002FALT \\> 3 x the upper limit of normal range (ULN), regardless of the level of total bilirubin\n   * AST\u002FALT \\> 1.5 and ≤ 2 x ULN and total bilirubin is \\> ULN\n   * Total bilirubin \\> 2 x ULN, regardless of the level of AST\u002FALT\n4. Any known\u002Fsuspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening.\n5. Pregnant or nursing (lactating) women, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of effective contraception, and sexually active patients not willing to practice effective contraception.\n6. History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as:\n\n   * Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker\n   * History of familial long QT syndrome or known family history of Torsades de Pointe.\n   * Resting heart rate (physical exam or 12 lead ECG) \\\u003C 50 bpm\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","2 Years","100 Years",{"count":562,"type":23},327,[130],"Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria",[566],"Uncomplicated Plasmodium Falciparum Malaria",[134,568,135,569,557],"uncomplicated malaria","platform study","2025-07-29",{"date":419,"type":40},{"date":573,"type":40},"2024-01-23",{"date":575,"type":23},"2026-06-23",{"name":577,"class":117},"Novartis Pharmaceuticals",12,{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":57,"minAge":93,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":24,"phases":588,"briefSummary":589,"conditions":590,"keywords":592,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":605},"100586206","continous-positive-airway-pressure-cpap-support-for-acute-hypoxemic-respiratory-failure-in-burkina-faso-100586206","NCT06912360","Continous Positive Airway Pressure (CPAP) Support for Acute Hypoxemic Respiratory Failure in Burkina Faso","Use of (Continous Positive Airway Pressure) CPAP in the Management of Acute Hypoxemic Respiratory Failure","Inclusion Criteria:\n\nAll patients aged 18 years and older will be included in the study if they meet at least one of the following criteria :\n\n* Acute respiratory distress, defined as dyspnea respiratory rate ≥ 25 cycles\u002Fmin\n* Hypoxemia, defined as the need for more 6 liters of oxygen to maintain an oxygen saturation (SpO2) of ≥ 92%. The fraction of inspired oxygen (FiO2) will be estimated using the 3% rule.\n\nExclusion Criteria:\n\nPatients with any of the following criteria will not be included in the study:\n\n* Pregnant or breastfeeding women\n* Persons deprived of their liberty\n* Exacerbation of asthma, chronic obstructive pulmonary disease, or another chronic respiratory disease\n* Moderate to large amount of unilateral or bilateral undrained pleural effusion\n* Contraindication to CPAP: patient refusal, undrained pneumothorax, chest injury, repeated or large vomiting, upper gastrointestinal bleeding, craniofacial trauma, severe upper airway obstruction, or tetraplegia in the initial phase\n* Cardiac arrest, severe arrhythmias, shock requiring the use of vasopressors (norepinephrine, adrenaline, dopamine)\n* Altered level of consciousness (Glasgow Coma Scale score \\\u003C 13), repeated seizures, or status epilepticus\n* Medical decision to limit treatment: no intubation, no admission to intensive care\n* Refusal to participate in the study or participation in another interventional study on respiratory distress or acute respiratory failure.",{"count":587,"type":23},240,[260],"Acute respiratory failure (ARF) is a frequent medical emergency, involving high costs for health organizations and patients who often require intensive care and respiratory assistance. According to an international study, 61% of hypoxemic patients in intensive care receive invasive ventilation \\[3\\]. Invasive mechanical ventilation is often unavailable in low-income countries and non-invasive ventilatory supports such as continuous positive airway pressure (CPAP) and high-flow oxygen therapy (HFO) were very useful during the COVID-19 pandemic. They reduced the rate of intubation and ICU admissions. In addition, CPAP can be used without a ventilator, no electricity is required. So, it could be a support of choice in low-income countries.\n\nUsed of Boussignac-type CPAP could potentially reduce the recourse to intubation in patients with acute hypoxemic respiratory failure in a context where access to invasive ventilation remains very limited.",[591],"Acute Respiratory Failure",[593,594,595],"CPAP","Acute hypoxemic respiratory failure","Africa","2025-07-23",{"date":598,"type":40},"2025-07-28",{"date":600,"type":40},"2025-07-09",{"date":602,"type":23},"2026-02-20",{"name":604,"class":47},"Université NAZI BONI",4,{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":18,"sex":57,"minAge":613,"maxAge":614,"enrollmentInfo":615,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":617,"conditions":618,"keywords":621,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":118},"100574454","validation-and-simplification-of-the-retinol-isotope-dilution-technique-in-burkinabe-schoolchildren-100574454","NCT06759493","Validation and Simplification of the Retinol Isotope Dilution Technique in Burkinabe Schoolchildren","RID_VAB","Inclusion Criteria:\n\n* School children aged 7-12 years\n\n  * Child's guardian or parent is willing to provide informed consent\n  * Child's family plans to remain resident in the study areas during the study period\n\nExclusion Criteria:\n\n* Clinical evidence of vitamin A deficiency a mis en forme : Anglais (Royaume-Uni)a mis en forme : Anglais (États-Unis)a mis en forme : Anglais (États-Unis)a mis en forme : Anglais (États-Unis)\n\n  * Severe malnutrition (weight-for age Z score (WAZ) or height-for-age Z score (HAZ) \\\u003C-3 SD)\n  * Serious illnesses including tuberculosis, symptomatic HIV infection\n  * Child aged \\\u003C6 years or \\>12 years","7 Years","12 Years",{"count":616,"type":23},158,"Two cross-sectional, repeated-pass, community-based studies will be carried out during the school year. The first study will be conducted from November to December. This period corresponds to the end of the rainy season and the end of the mango season, which is one of the main sources of vitamin A in the Orodara region.\n\nThe second survey will be carried out 5 to 6 months (April-May of the following year) after data collection for the first study, corresponding to the mango season. The same schoolchildren recruited during the first phase of data collection (5 to 6 months earlier) will be the participants in the second study. The interest of this study is to use nuclear techniques to implement a strategy for the precise and accurate determination of Vitamin A status in order to reinforce existing Vitamin A interventions and policies.",[619,620],"Vitamin A Deficiency","Inflammation",[622,623,624,625,74],"Vitamin A","School","children","Isotope","2025-03-16",{"date":628,"type":40},"2025-03-18",{"date":630,"type":40},"2024-11-21",{"date":632,"type":23},"2025-06-30",{"name":634,"class":334},"Institut de Recherche en Sciences de la Sante, Burkina Faso",{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":18,"sex":57,"minAge":58,"maxAge":642,"enrollmentInfo":643,"targetDuration":4,"studyType":24,"phases":645,"briefSummary":646,"conditions":647,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":118},"100500025","phase-1-a-study-to-test-experimental-blood-stage-malaria-vaccine-in-burkina-faso-100500025","NCT05790889","A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.","A Phase IIb Randomised Controlled Trial of the Safety, Immunogenicity and Efficacy of the Blood-stage Malaria Vaccine Candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in Infants Aged 5-17 Months in Burkina Faso.","Inclusion Criteria:\n\n1. Healthy infant aged 5-17 months at the time of first study vaccination\n2. Parent\u002Fguardian provides signed\u002Fthumb-printed informed consent\n3. Infant and parent\u002Fguardian resident in the study area villages and anticipated to be available for vaccination and follow-up for 12 months following last dose of vaccination.\n\nExclusion Criteria:\n\n* Clinically significant congenital abnormalities as judged by the PI or other delegated individual.\n* Clinically significant skin disorder (psoriasis, contact dermatitis etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual.\n* Weight-for-age Z score of less than -3 or other clinical signs of malnutrition.\n* History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunization.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n* Sickle cell disease.\n* Clinically significant laboratory abnormality as judged by the study clinician.\n* Administration of immunoglobulins and\u002For any blood products within the three months preceding the planned administration of the vaccine candidate.\n* Receipt of any vaccine in the 7 days preceding enrolment, or planned receipt of any other vaccine within 7 days following each study vaccination.\n* History of vaccination with another malaria vaccine.\n* Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.\n* Known maternal HIV infection (no testing will be done by the study team).\n* Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (for corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg\u002Fkg\u002Fday; inhaled and topical steroids are allowed).\n* Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.","17 Months",{"count":644,"type":23},480,[98,130],"This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso",[183],"2025-03-04",{"date":650,"type":40},"2025-03-07",{"date":652,"type":40},"2023-04-03",{"date":654,"type":23},"2026-05-30",{"name":192,"class":47},{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":256,"eligibilityCriteria":662,"healthyVolunteers":18,"sex":57,"minAge":93,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":24,"phases":665,"briefSummary":666,"conditions":667,"keywords":677,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":685,"completionDateStruct":686,"leadSponsor":688,"locationsCount":118},"100580848","assessing-the-effect-of-cool-roofs-on-health-using-smartwatches-in-ouagadougou-burkina-faso-100580848","NCT06842641","Assessing the Effect of Cool Roofs on Health Using Smartwatches in Ouagadougou, Burkina Faso","A Cluster Randomized Controlled Trial (cRCT) Evaluating the Effects of Cool Roofs on Health Outcomes Using Smartwatches in Ouagadougou, Burkina Faso","Inclusion Criteria:\n\n* • Permanent household resident\n\nExclusion Criteria:\n\n* • Roof damage, inaccessible or instability of roof adversely affecting cool roof coating application.\n\n  * Participant unable to provide written\u002Fverbal informed consent. Participants will be excluded if they are not willing or able to wear a smartwatch.\n  * One participant per household.",{"count":664,"type":23},200,[260],"Ambient air temperatures in Africa, have broken record highs in 2024. Solutions are needed to build heat resilience in communities and adapt to increasing heat from climate change. Sunlight-reflecting cool roof coatings may passively reduce indoor temperatures and energy use to protect home occupants from extreme heat. Occupants living in poor housing conditions- for example in informal settlements, slums, and low-socioeconomic households - are susceptible to increased heat exposure.\n\nHeat exposure can instigate and worsen numerous physical, mental and social health conditions. The worst adverse health effects are experienced in communities that are least able to adapt to heat exposure. By reducing indoor temperatures, cool roof application may improve heart health, sleep and physical activity in household occupants.\n\nThe long-term research goal is to identify viable passive housing adaptation technologies with proven health benefits to reduce the burden of heat stress in communities affected by heat. To meet this goal, the investigators will use smartwatches to measure the effects cool roof application on heart health, sleep and physical activity in Ouagadougou, Burkina Faso.",[668,669,670,671,672,673,674,675,676],"Heart Rate","All-day Steps","Distance Walked","Active Minutes","Moderate-intensity Activity Minutes","Sleep Quantity","Time in Sleep Stages","Awake Duration","Sleep Score",[289,290,291,678,679,292,293,680,681,297],"Wearable","Smartwatch","Physical activity","Sleep","2025-02-18",{"date":684,"type":40},"2025-02-24",{"date":397,"type":23},{"date":687,"type":23},"2026-03-20",{"name":689,"class":47},"Institut Supérieur des Sciences de la Population",{"id":691,"slug":692,"hasResults":12,"nctId":693,"briefTitle":694,"officialTitle":695,"acronym":696,"eligibilityCriteria":697,"healthyVolunteers":12,"sex":57,"minAge":239,"maxAge":432,"enrollmentInfo":698,"targetDuration":4,"studyType":24,"phases":700,"briefSummary":701,"conditions":702,"keywords":704,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":714,"lastUpdatePostDateStruct":715,"startDateStruct":717,"completionDateStruct":719,"leadSponsor":721,"locationsCount":118},"100576982","effectiveness-of-an-alternative-protocol-in-the-management-of-acute-malnutrition-100576982","NCT06792370","Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition","Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition in Children Aged 6-59 Months in Burkina Faso: Reduced Dose of RUTF for SAM Children and RUTF Instead of RUSF for MAM Children","Alternat-MAL","1. MAM\n\n   Inclusion Criteria:\n   * Anthropometric measures:\n\n     * (115 mm ≤ MUAC\\\u003C 125 mm and -3 SDs ≤ WLZ \\\u003C -2 SDs) OR\n     * (115 mm ≤ MUAC\\\u003C 125 mm and WLZ ≥ -2 SDs) OR\n     * (MUAC ≥ 125 mm and -3 SDs ≤ WLZ \\\u003C -2 SDs).\n   * Age: 6 to 59 months\n   * Parents' acceptance of biweekly visits until programme discharge and monthly visits for the post-programme follow up\n\n   Exclusion Criteria:\n   * Failure of appetite test\n   * Medical complications requiring hospital treatment\n   * Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection\n   * Presence of bilateral oedema\n   * History of allergies to peanuts, milk, or soya\n   * Relapse from MAM treatment or transfer from SAM treatment\n   * Children who have recently (\\\u003C2 months) taken part in a nutrition programme;\n   * Residence outside the study area\n   * Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)\n2. SAM\n\nInclusion Criteria:\n\n* Anthropometric measures MUAC\\\u003C 115 mm or WLZ\\\u003C - 3 SDs;\n* Age: 6-59 months;\n* Parents' acceptance of weekly visits until programme discharge and monthly visits for the post-programme follow up.\n\nExclusion Criteria:\n\n* Failure of appetite test\n* Medical complications requiring hospital treatment\n* Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection\n* Presence of bilateral oedema\n* History of allergies to peanuts, milk or soya\n* Relapse from MAM treatment or transfer from SAM treatment\n* Children who have recently (\\\u003C2 months) taken part in a nutrition programme;\n* Residence outside the study area;\n* Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)",{"count":699,"type":23},3521,[260],"This experimental study aims to test an alternative protocol for managing acute malnutrition in children aged 6-59 months in Burkina Faso. This alternative protocol consists of using RUTF instead of RUSF for the management of moderate acute malnutrition and reduced-dose RUTF instead of standard-dose RUTF for the treatment of severe acute malnutrition.\n\nThe main questions are:\n\n1. Does treating children with moderate acute malnutrition using RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with RUSF?\n2. Does treating children with uncomplicated severe acute malnutrition using a reduced dose of RUTF lead to a non-inferior programmatic and sustained recovery rate compared to the standard care with a standard dose of RUFT?\n\nSecondly, the study will investigate the effect of this alternative protocol compared to the standard protocol on cost-effectiveness, psychomotor development, weight and linear growth and incidence of relapses.",[703],"Acute Malnutrition with No Complications",[705,706,707,708,709,710,711,712,713],"Effectiveness","acute malnutrition","management","treatment","reduced dose","Ready-to-Use Supplementary Foods","Ready-to-Use Therapeutic Foods","uncomplicated","without complication","2025-01-20",{"date":716,"type":40},"2025-01-24",{"date":718,"type":23},"2025-05",{"date":720,"type":23},"2026-12",{"name":634,"class":334},""]