[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Guinea\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":168},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,90,114,144],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100629626","phase-4-linezolid-tolerance-during-the-bpal-regimen-with-dosage-personalization-based-on-therapeutic-drug-monitoring-tdm-during-multidrug-resistant-tuberculosis-treatment-100629626",false,"NCT07477119","Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment","Tolérance du Linézolide Pendant le Régime BPaL Avec Personnalisation de la Posologie Basée Sur la Surveillance Thérapeutique Des Médicaments (TDM) au Cours du Traitement de la Tuberculose Multirésistante","PLOT-TB","Inclusion Criteria:\n\n* 1\\. Confirmed diagnosis of MDR-TB\n* 2\\. Linezolid prescribed as part of the BPaL\u002FBPaL-M regimen\n* 3\\. Age 15 years or older\n* 4\\. Informed consent obtained from the participant or assent from the parent\u002Flegal guardian for participants under 18 years of age.\n\nExclusion Criteria:\n\n* 1\\. Pregnancy or breastfeeding\n* 2\\. Severe liver or kidney failure\n* 3\\. Known hypersensitivity to linezolid\n* 4\\. Concomitant use of medications with drug interactions potential with linezolid","ALL","15 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge to global public health.\n\nGlobally, the World Health Organization (WHO) estimates the number at 400,000 patients with MDR-TB for 2023. Only 44% were diagnosed and put on treatment, the therapeutic success rate of the 2021 cohort is only 68%.\n\nIn Guinea, the number of patients with MDR-TB is estimated at 450, and the treatment success rate is 74% for the 2021 cohort, primarily with the 9-months short oral regimen.\n\nSince 2022, the WHO has recommended the use of the 6-month short course of BPaL\u002FBPaL-M for national tuberculosis control programs and Guinea began implementing this new regime within the programmatic framework starting in January 2025.\n\nLinezolid, a key component of new therapeutic regimens such as BPaL\u002FBPaL-M, shows high bactericidal activity, although it is associated with serious adverse effects in a high percentage of patients, including myelosuppression, neuropathy and, in some cases, fatal lactic acidosis. In particular, peripheral neuropathy, an adverse event often irreversible that may lead to linezolid and the BPaL\u002FBPaL-M regimen discontinuation, is reported in approximately 24% of patients receiving linezolid at 600 mg.\n\nA linezolid blood trough level of above 2 mg\u002Fl is associated with side effects, but its pharmacokinetics varies considerably between individuals and over time.\n\nThere is little data on the role of therapeutic drug monitoring (TDM) in guiding its administration, some studies showing how the standard dose of 600 mg could exceed the toxicity target and the reduced dose of 300 mg might not achieve the target efficacy.\n\nThe main objective of this study is to determine the role of TDM in the optimization of linezolid dosage in TB-MDR patients treated with the BPaL\u002FBPaL-M regimen.\n\nThe specific objectives aim to evaluate:\n\n* the variation in the occurrence of adverse events between patients who undergo a modification of the linezolid dose based on the TDM and patients taking linezolid standard dose\n* the treatment outcome in patients who undergo a modification of the linezolid dose based on TDM and patients taking linezolid standard dose\n* variations in the distribution of TDM throughout treatment in order to identify potential common trends.",[27,28,29],"Linezolid","Tuberculosis Multi Drug Resistant Active","Therapeutic Drug Monitoring (TDM)",[31,32,33,34,35,36,37,38,39],"linezolid","TDM","Therapeutic Drug Monitoring","MDR-TB","Guinea","Adverse Drug Reaction","Peripheral Neuropathy","Myelosuppression","Tuberculosis","RECRUITING","2026-05-11",{"date":43,"type":44},"2026-05-13","ACTUAL",{"date":46,"type":21},"2026-04",{"date":48,"type":21},"2028-04",{"name":50,"class":51},"Marco Schiuma","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":62,"targetDuration":64,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":88,"locationsCount":52},"100634021","understanding-mpxv-viral-clearance-transmission-dynamics-and-mpox-vaccine-effectiveness-in-west-africa--guinea-100634021","NCT07534267","Understanding MPXV Viral Clearance, Transmission Dynamics, and Mpox Vaccine Effectiveness in West Africa : Guinea","Understanding MPXV Viral Clearance in Mpox Patients and Evaluating Transmission Dynamics of MPXV and Mpox Vaccine Effectiveness in West Africa : The Republic of Guinea","MOVIE-TRACE-WA","Inclusion Criteria:\n\n1. MOVIE-West Africa\n\n   * Individuals of any sex and age.\n   * Confirmed Mpox cases who tested positive for MPXV by PCR.\n   * Symptom onset within the 10 days prior to the baseline assessment.\n   * Willingness and ability to comply with study procedures and attend scheduled follow-up visits for up to two months.\n   * Availability for follow-up throughout the study period.\n   * Provision of written informed consent by the participant, or consent by a legally authorized representative for minors or individuals unable to provide it themselves.\n   * Assent obtained from children aged 12 to 17 years.\n   * For individuals who cannot read or write, witnessed consent will be obtained.\n2. TRACE-West Africa\n\n   * Individuals who have had close physical contact with a PCR-confirmed Mpox case within 14 days from the onset of symptoms in the index case.\n   * Close physical contact is defined as being within 2 meters of an infected person-particularly in enclosed spaces-for at least 5 minutes (based on CDC's 2-meter rule for droplet transmission).\n   * Willingness and ability to comply with the study protocol and attend scheduled follow-up assessments.\n   * Provision of written informed consent by the participant, or consent by a legally authorized representative for individuals unable to provide it themselves.\n   * Assent obtained from children aged 12 to 17 years.\n   * For individuals who cannot read or write, witnessed consent will be obtained.\n3. VE-West Africa\n\n   * The inclusion criteria for Mpox cases in VE-West Africa are same as those in MOVIE-West Africa.\n   * The inclusion criteria for contacts of Mpox cases in VE-West Africa are as follows.\n   * Individuals who have had close physical contact with a PCR-confirmed Mpox case within 14 days from the onset of symptoms in the index case.\n   * Close physical contact is defined as being within 2 meters of an infected person-particularly in enclosed spaces-for at least 5 minutes (based on CDC's 2-meter rule for droplet transmission).\n   * Individuals living, working or studying in a community where mpox vaccination is being offered.\n   * Willingness and ability to comply with the study protocol and attend scheduled follow-up assessments.\n   * Provision of written informed consent by the participant, or consent by a legally authorized representative for individuals unable to provide it themselves.\n   * Assent obtained from children aged 12 to 17 years.\n   * For individuals who cannot read or write, witnessed consent will be obtained.\n\nExclusion Criteria:\n\n(1) MOVIE-West Africa\n\n* Cases of severe Mpox requiring hospitalization.\n* Individuals with a confirmed alternative diagnosis explaining their illness.\n\n  (3) VE-West Africa\n* The exclusion criteria for Mpox cases in VE-West Africa are as follows.\n* Cases of severe Mpox requiring hospitalization.\n* Individuals with a confirmed alternative diagnosis explaining their illness.",true,{"count":63,"type":21},992,"56 Days","OBSERVATIONAL","This study has three primary objectives to address the public health challenges of the Mpox outbreak in Guinea, West Africa. Objective 1 (MOVIE-West Africa) focuses on understanding the kinetics of Monkeypox virus (MPXV) elimination from the human body in Mpox cases. Objective 2 (TRACE-West Africa) aims to determine the MPXV transmission dynamics between Mpox cases and their contacts. Objective 3 (VE-West Africa) examines the vaccine effectiveness of the MVA-BN vaccine in protection against MPXV infection and Mpox disease.",[68,69],"Mpox (Monkeypox)","Monkeypox",[71,69,72,73,74,75,76,35,77,78,79,80],"Mpox","MPXV","transmission dynamics","vaccine effectiveness","secondary attack rate","MVA-BN","sub-Saharan Africa","West Africa","MOVIE-TRACE","viral clearance","NOT_YET_RECRUITING","2026-04-10",{"date":84,"type":44},"2026-04-16",{"date":84,"type":21},{"date":87,"type":21},"2027-08",{"name":89,"class":51},"London School of Hygiene and Tropical Medicine",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":97,"enrollmentInfo":98,"targetDuration":100,"studyType":65,"phases":4,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100423472","recommendations-for-the-treatment-of-children-with-acute-lymphoblastic-leukemia-in-the-gfaop-100423472","NCT04794296","Recommendations for the Treatment of Children With Acute Lymphoblastic Leukemia in the GFAOP","LALGFA2019","Inclusion Criteria:\n\nChildren 0 to 18 ALL first diagnosis No prior chemotherapy Cytology FAB L1 or L2\n\n\\-\n\nExclusion Criteria:\n\nALL L3 (Burkitt) ALL previously treated with chemotherapy Trisomy 21","18 Years",{"count":99,"type":21},500,"10 Years","The LALGFA2019 Recommendations redefine the standard risk criteria and propose to introduce anthracycline induction in so-called high-risk forms (LAL line T and LAL line B with leukocytosis greater than or equal to 50 G\u002FL or in children less than 1 year of age or more than 10 years of age) as well as Endoxan and Methotrexate in high dose consolidation.",[103],"Childhood ALL","2026-02-27",{"date":106,"type":44},"2026-03-02",{"date":108,"type":44},"2021-11-15",{"date":110,"type":21},"2030-12-31",{"name":112,"class":51},"French Africa Pediatric Oncology Group",3,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":143},"100580769","phase-3-ebola-post-exposure-prophylaxis-100580769","NCT06841614","EBOla Post-Exposure Prophylaxis","Evaluation of the Efficacy of a Post-exposure Prophylaxis (PEP) Strategy in Contacts at High Risk of Developing Ebola Virus Disease (EVD)","EBO-PEP","Inclusion criteria\n\n* Last high-risk contact within the last 5 days\n* No sign or symptoms of EVD\n* Signed and dated informed consent from participants over the age of majority to participate in the trial or from a representative of parental authority for minor participants.\n\nNon-inclusion criteria\n\n* History of vaccination with Ervebo or any other EVD vaccine within the last 5 years (self-reported by the participant)\n* History of confirmed EVD within the last 5 years (self-reported by the participant)\n* Hypersensitivity to any of the experimental medical products (IMP) or their excipients (self-reported by the participant)\n* Participation in another therapeutic or vaccine trial for EVD\n* Any other reason that, at the investigator's discretion, could compromise the participant's safety and cooperation in the trial.",{"count":123,"type":21},160,[125],"PHASE3","EBO-PEP is a multicentre, multi-epidemic, phase III, comparative, controlled, randomised, strict superiority trial in two unblinded parallel arms.\n\nThe trial will be open during EVD epidemics and will recruit asymptomatic participants at high risk of developing EVD.\n\nParticipants will be randomized (1:1) into one of two trial arms:\n\n* Arm 1 (ERV): Ervebo D0 (72 million PFU IM)\n* Arm 2 (ERV+IMZ): Ervebo D0 (72 million PFU IM) + Inmazeb IV (150 mg\u002Fkg) D0 + Ervebo D56 (revaccination)\n\nDefinition of high-risk:\n\nDirect contact with a person with EBOV PCR-confirmed EVD with diarrhea, vomiting or external bleeding (\"wet symptoms\"), or with their body fluids; Direct contact with the dead body of a person with confirmed or probable EVD; Needlestick with a syringe contaminated by the blood of a person with confirmed or probable EVD; Or a child born to or breastfed by an individual with EVD\n\nTrial follow-up All participants are monitored daily for a minimum of 21 days.\n\nSome visits are conducted in person at the investigation site, also called the Post-Exposure Prophylaxis (PEP) center:\n\n* at Day 5, Day 10, and Day 21 for the ERV arm,\n* at Day 5, Day 10, Day 21, and Day 56 for the ERV+IMZ arm. Other visits are conducted at home or by phone, in collaboration with the Ministry of Health's surveillance team.\n\nParticipants in the ERV+IMZ arm have an in-person visit at Day 56 to be revaccinated with the Ervebo vaccine to compensate for potential inhibition of the vaccine response when Ervebo is administered simultaneously with Inmazeb.\n\nParticipants in the ERV arm have a phone visit at Day 56. For all participants, a phone visit is scheduled at Day 60. It corresponds to the last visit for all trial participants.\n\nFollow-up in Case of Hospitalisation In case of clinical signs suggestive of EVD, participants enter the suspected case management pathway at the Ebola Treatment Center (ETC).\n\nIf EVD is confirmed by EBOV PCR, participants are allowed at the ETC, and their study samples are discontinued. They continue to be followed by the research team, and daily data are collected throughout their stay at the ETC until they are discharged alive or deceased. The day of discharge from the ETC marks the end of follow-up in the study for these participants.\n\nOf note, participants in the ERV+IMZ arm who have confirmed EVD are not revaccinated at day 56.\n\nOf note, participants in the ERV+IMZ arm who have confirmed EVD are not revaccinated at day 56.\n\nIf EVD is not confirmed, participants continue to be followed up by the PEP center according to the protocol.",[128],"Ebola Virus Disease",[128,130,131,132],"EBOV","High-Risk contact","Post-Exposure Prophylaxis","2026-01-21",{"date":135,"type":44},"2026-01-22",{"date":137,"type":21},"2026-09",{"date":139,"type":21},"2028-08-01",{"name":141,"class":142},"ANRS, Emerging Infectious Diseases","OTHER_GOV",4,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":152,"maxAge":4,"enrollmentInfo":153,"targetDuration":155,"studyType":65,"phases":4,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":52},"100525478","febrile-illness-in-guinea-100525478","NCT06122259","Febrile Illness in Guinea","Multidisciplinary Surveillance and Investigation of Febrile Illness in Guinea","MuSIFe","Inclusion Criteria:\n\n* Age ≥2 months old\n* Documented fever (axillary temperature \\>37.5°C) at presentation or fever reported within the prior 24 hours\n* Availability for follow-up for 21 days\n* Willingness and ability of the patient or culturally acceptable representative to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* History of hospitalization (for \\> 48 hours within the last 14 days) at any health facility","2 Months",{"count":154,"type":21},2500,"21 Days","To date, the underlying causes of community-acquired fever, particularly non-malarial fever, are insufficiently documented in Guinea. Moreover, diagnostic capacity is limited, leading to inadequate prescription of antibiotics and antimalarials, as well as substantial delay in outbreak recognition. Thus, the investigators undertook a prospective observational multi-centric cohort study of febrile patients presenting at the emergency and outpatient department of selected health centers, districts and regional hospitals in four ecologically distinct sentinel health districts in Guinea.",[158],"Febrile Illness","2023-11-07",{"date":161,"type":44},"2023-11-08",{"date":163,"type":44},"2023-03-27",{"date":165,"type":21},"2026-12-31",{"name":167,"class":142},"Centre National de Formation et de Recherche en Sante Rurale",""]