[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Niger\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":197},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,78,108,135,168],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100543669","phase-4-azithromycin-for-child-survival-in-niger-ii-100543669",false,"NCT06358872","Azithromycin for Child Survival in Niger II","Azithromycine Pour la Vie Des Enfants au Niger II","AVENIR II","Inclusion Criteria:\n\nCSI-level for mortality and AMR monitoring:\n\n* Located in a region participating in the program\n* Designated as rural by local study team\n* Selected for participation in monitoring activities\n* Safe and accessible for study teams\n* Verbal approval from community leaders\n\nIndividual level for mortality monitoring:\n\n* Residing in the catchment area of an eligible CSI\n* Selected for participation in monitoring activities\n* Female\n* Age between 12 and 55 years old\n* Verbal approval from participant\n\nIndividual-level for AMR monitoring:\n\n* Residing in the catchment area of an eligible CSI\n* Selected for participation in monitoring activities\n* Age between 1 and 59 months old\n* Verbal approval from a caregiver or guardian\n\nExclusion Criteria:\n\nAt the community-level:\n\n* Designated as urban by local study team\n* Inaccessible or unsafe for study team\n\nAt the individual-level:\n\n* Known allergy to macrolides",true,"ALL","1 Month","59 Months",{"count":22,"type":23},3300000,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years.",[29,30],"Mortality","Antimicrobial Resistance",[32,33,34,30,35],"Mass Treatment","Azithromycin","Childhood Mortality Rate","Implementation and Cost Analysis","RECRUITING","2026-08-13",{"date":39,"type":40},"2026-08-17","ACTUAL",{"date":42,"type":40},"2024-04-29",{"date":44,"type":23},"2028-04-29",{"name":46,"class":47},"University of California, San Francisco","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":48},"100647684","integrating-the-guardian-spatial-emanator-within-avenir-ii-100647684","NCT07712263","Integrating the Guardian Spatial Emanator Within AVENIR II","GUARD-AV","Inclusion Criteria:\n\n* Centre de Santé Intégré (CSI) catchment area participating in the AVENIR II azithromycin mass drug administration program\n* Located in a high malaria transmission setting in the study area\n* Randomly selected from the eligible pool for participation\n* Household located within a selected CSI catchment area\n* Verbal consent provided by the head of household for household-level study activities\n* Verbal consent provided by the CSI chief for CSI-level participation\n\nExclusion Criteria:\n\n* CSI catchment area not participating in the AVENIR II azithromycin mass drug administration program\n* Household not located within a selected CSI catchment area\n* Refusal of verbal consent by the head of household\n* Refusal of verbal consent by the CSI chief for CSI-level participation",{"count":57,"type":23},150000,[59],"NA","This study will evaluate the implementation of integrating Guardian spatial emanators into the existing AVENIR II azithromycin mass drug administration program in Niger. The objective is to assess whether Guardian can be feasibly, acceptably, and effectively delivered through the same community-based platform already used for door-to-door azithromycin distribution to children 1 to 59 months of age.\n\nSelected health center catchment areas in high-malaria-transmission settings in Niger will be randomized to integrated delivery or non-integrated delivery. The study will measure implementation outcomes including reach, coverage, acceptability, fidelity to protocol, costs, and product placement over time, and will also assess malaria-related clinic visits among children under 5 years of age using routine health facility data",[62],"Malaria",[64,65,66,67,68],"transfluthrin","malaria","spatial emanator","implementation science","cluster randomized","NOT_YET_RECRUITING","2026-07-20",{"date":72,"type":40},"2026-07-22",{"date":74,"type":23},"2026-12-01",{"date":76,"type":23},"2028-12-31",{"name":46,"class":47},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":17,"sex":18,"minAge":86,"maxAge":20,"enrollmentInfo":87,"targetDuration":4,"studyType":24,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100639425","optimax-will-test-whether-sq-lns-incentivises-vaccination-uptake-in-rural-chad-and-niger-with-a-cost-effectiveness-analysis-it-will-also-look-at-whether-having-received-sq-lns-before-becoming-malnourished-leads-to-better-outcomes-for-children-treated-under-the-optima-protocol-100639425","NCT07592260","OptiMAx Will Test Whether SQ-LNS Incentivises Vaccination Uptake in Rural Chad and Niger, With a Cost Effectiveness Analysis. It Will Also Look at Whether Having Received SQ-LNS Before Becoming Malnourished Leads to Better Outcomes for Children Treated Under the OptiMA Protocol.","OptiMAx: Incentivizing EPI Vaccination Via Distribution of SQ-LNS Nutritional Supplementation to Children From Age 6-11 Months Until 18 Months of Age in Rural Chad and Niger, With a Cost Effectiveness Analysis Protocol for a Research Study Nested in the OptiMA Research Study in Ngouri Health District, Lake Region, Chad and Mirriah Health District, Zinder Region, Niger","OptiMAx","Inclusion Criteria:\n\n* All non-malnourished children between 6 and 12 months of age will be eligible for SQ-LNS supplementation until they reach 18 months of age.\n\nFor the annual household surveys,\n\n* Children aged 6 to 59 months will be surveyed on MUAC status and other malnutrition-related issues, while the immunization analysis will focus on children aged 12 to 23 months;\n* With the informed oral consent of the parents or legal guardian ;\n* Reside in the neighborhoods included in the study.\n\nFor the mixed-methods process evaluation and gender sub-study (to be carried out in the months following implementation).\n\nInclusion criteria\n\n* OptiMAx intervention personnel (e.g. healthcare staff)\n* A group of mothers of children benefiting from the intervention\n* Male partners\u002Fspouses of parents\n* Community members from the sites targeted by the intervention will be recruited for the focus groups.\n* Non-adherents or parents who choose not to continue nutritional supplementation and\u002For vaccination despite their availability under the program will be recruited for interviews.\n* Husbands\u002Fmale partners of non-members will also be surveyed.\n\nExclusion Criteria:\n\n* Age-eligible children with MUAC \\\u003C125 or edema will first be treated for acute malnutrition with OptiMA and then resume supplementation with SQ-LNS.\n\nThere is no exclusion criteria for the annual household surveys\n\nExclusion criteria for the mixed-methods process evaluation\n\n\\- Parents or guardians under 15 years of age.","6 Months",{"count":88,"type":23},20000,[59],"Malnutrition and infectious disease form a vicious circle, posing a double threat to vulnerable children in low- and middle-income countries. Malnutrition makes children more vulnerable to infectious diseases, while infectious diseases increase the risk of malnutrition. When caught in this cycle, children are far more likely to die or suffer adverse effects on their health and development. High rates of wasting and low immunization coverage also constitute a weakening double burden for already fragile health systems. Every year in these contexts, hundreds of thousands of children are treated for severe wasting, while at the same time suffering repeated and prolonged epidemics of vaccine-preventable diseases such as measles. Rural areas of Chad and Niger are at the heart of this dynamic, recording some of the worst indicators of malnutrition and low vaccination coverage rates.\n\nSmall-quantity lipid-based nutritional supplements (SQ-LNS) are a category of ready-to-use, nutrient-dense food supplements fortified with micronutrients, designed to prevent malnutrition and improve child survival, growth and development. A recent meta-analysis on SQ-LNS reveals that giving a child just one sachet of SQ-LNS a day for a year can reduce the risk of mortality by 27%, iron-deficiency anemia by 64%, severe wasting by 31% and severe stunting by 17%. The recent World Health Organization (WHO) guideline on complementary feeding of infants and young children aged 6 to 23 months recently recommended the use of SQ-LNS in certain contexts of food insecurity, based on evidence deemed \"very safe\".\n\nThe distribution of SQ-LNS is also promising as an incentive for vaccination, as well as for other health services, such as participation in infant growth monitoring programs. Various operational experiences suggest that it is likely to have an impact on increasing vaccination coverage, and a modeling simulation suggests that it would lead to a significant reduction in measles morbidity and mortality.\n\nThe main objective of OptiMAx is to estimate the effectiveness of a mass SQ-LNS supplementation program coupled with the routine immunization program compared with the routine immunization program alone in terms of vaccination coverage against pentavalent 1 (Niger) and measles 1 (Chad), after 12 months of program implementation, in children aged 12 to 23 months as part of an annual cross-sectional household survey.\n\nSecondary objectives include:\n\n* Estimate the effectiveness of a mass SQ-LNS supplementation program combined with the routine Essential Program on Immunization (EPI) compared with the routine EPI alone in children aged 6-18 months, after 12 months of program implementation, in terms of 1) coverage of pentavalent 3 vaccine, malaria and other childhood vaccines, 2) on-time immunization for age-eligible children.\n* Evaluate the feasibility and reliability of combining measles and pentavalent coverage measurements during annual MUAC-family training campaigns;.\n* Evaluate outcomes of acutely malnourished children who received SQ-LNS supplementation prior to RUTF treatment (as part of their inclusion in the OptiMA study) versus those who did not receive SQ-LNS supplementation\n\nThe specific objectives of the process evaluation (with a sub-study on gender), modeling and economic evaluation are as follows:\n\n1. Conduct a process evaluation of the OptiMAx intervention to understand how it works, for whom and where;\n2. Understand to what extent and how gender-related facilitations and barriers affect the interaction and uptake of intervention, both on the demand side (health-seeking\u002Fintervention behaviors) and the supply side (provision of intervention services).\n3. Estimate the health impact of the OptiMAx intervention, in terms of nutrition and vaccine-preventable diseases, using mathematical modeling approaches.\n4. Quantify the relative costs associated with the OptiMAx intervention compared with the costs associated with existing vaccination activities in Mirriah, Niger, and Ngouri, Chad.\n5. Estimate the cost-effectiveness of the OptiMAx intervention in Mirriah, Niger, and Ngouri, Chad.",[92,93],"Malnutrition Severe","Vaccination",[95,96,97],"routine immunization","SQ-LNS supplementation","acute malnutrition","2026-05-11",{"date":100,"type":40},"2026-05-18",{"date":102,"type":40},"2025-05-01",{"date":104,"type":23},"2026-12",{"name":106,"class":47},"Alliance for International Medical Action",2,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":18,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":120,"studyType":121,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"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","18 Years",{"count":119,"type":23},10000,"12 Months","OBSERVATIONAL","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.",[124],"Pediatric Cancer","2025-09-29",{"date":127,"type":40},"2025-10-03",{"date":129,"type":40},"2016-01-01",{"date":131,"type":23},"2030-12",{"name":133,"class":47},"French Africa Pediatric Oncology Group",14,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":24,"phases":145,"briefSummary":147,"conditions":148,"keywords":153,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":48},"100382503","phase-3-novel-triple-dose-tuberculosis-retreatment-regimen-100382503","NCT04260477","Novel Triple-dose Tuberculosis Retreatment Regimen","Novel Triple-dose Tuberculosis Retreatment Regimen: How to Overcome Resistance Without Creating More in Niger","Tri-Do-Re","Inclusion Criteria:\n\n* All newly registered patients with smear-positive recurrent pulmonary TB\n* Adults as well as children (no age limit)\n* Able and willing to provide written informed consent\n* Added for stage 2: lives within 5 km of a health facility with a medical doctor\n\nExclusion Criteria:\n\n* All patients with TB initially resistant to rifampicin on Xpert MTB\u002FRIF testing\n* Patients transferred to a health facility not supported by the Damien Foundation\n* Patients previously enrolled in the trial, and with another episode of rifampicin-susceptible TB during the study period\n* Those with grade III elevation of liver function tests at baseline, or with clinically active liver disease at screening\n* Pregnant or breastfeeding woman\n* HIV co-infected patients requiring treatment with a protease inhibitor",{"count":144,"type":23},370,[146],"PHASE3","To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).",[149,150,151,152],"Multidrug-resistant Tuberculosis","Pulmonary Tuberculosis","Tuberculosis","Resistance to Tuberculostatic Drugs",[154,151,155,156,157,158],"rifampicin-susceptible-TB","first-line","TB relapse","TB treatment failure","high dose retreatment","2025-04-10",{"date":161,"type":40},"2025-04-13",{"date":163,"type":40},"2021-03-01",{"date":165,"type":23},"2025-09",{"name":167,"class":47},"Institute of Tropical Medicine, Belgium",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":18,"minAge":86,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":24,"phases":177,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":48},"100545511","effectiveness-of-a-microbiome-directed-food-to-promote-programmatic-and-sustained-nutritional-recovery-among-children-with-uncomplicated-acute-malnutrition-100545511","NCT06382857","Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition","Inclusion Criteria:\n\n* for children with Severe Acute Malnutrition (SAM): MUAC \\\u003C 115 mm and\u002For WLZ \\\u003C -3 and\u002For mild (+) or moderate (++) edema\n* for children with Moderate Acute Malnutrition (MAM): 115 mm ≤ MUAC \\\u003C 125 mm and\u002For -3 ≤ WHZ \\\u003C -2\n* Caregiver providing informed consent\n\nExclusion Criteria:\n\n* Medical complications requiring inpatient treatment, as identified by the national protocol\n* Not eating\u002Flack of appetite (as informed by appetite test and investigator judgement)\n* Re-admission into the program within 2 months of previous default\n* for children with Severe Acute Malnutrition (SAM): Referral from inpatient care (therapeutic feeding center, TFC) or supplementary feeding program (SFP)\n* for children with Moderate Acute Malnutrition (MAM): Referral from SAM treatment (TFC or OTP)\n* Presence of congenital abnormality or underlying chronic disease that may affect growth or risk of infection\n* Known contraindication\u002F hypersensitivity\u002Fallergy to study interventions (chickpea\u002Fsoy flour, banana, peanut)\n* Residence outside the study catchment area or in a non-fixed (e.g. nomadic) community","23 Months",{"count":176,"type":23},7356,[59],"This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \\\u003C 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission.",[180],"Malnutrition, Child",[182,183,184,185,186,187],"Malnutrition","SAM","MAM","Child","MDF","Microbiome","2024-08-26",{"date":190,"type":40},"2024-08-27",{"date":192,"type":40},"2024-05-02",{"date":194,"type":23},"2026-02-01",{"name":196,"class":47},"Epicentre",""]