[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543669":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":65,"collaborators":67,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":39,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":47,"whyStopped":39,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous Distribution","ACTIVE_COMPARATOR","Azithromycin distribution to children 1-59 months of age for four years using a door-to-door delivery approach via existing community health workers",[13],"Drug: Azithromycin for Oral Suspension",{"label":15,"type":10,"description":16,"interventionNames":17},"Delayed Distribution","Delayed, by two years, azithromycin distribution to children 1-59 months of age using a door-to-door delivery approach via existing community health workers",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Stop Distribution","Stopping azithromycin distribution after two years to children 1-59 months of age using a door-to-door delivery approach via existing community health workers",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Azithromycin for Oral Suspension","Azithromycin will be administered as a single dose, in oral suspension form for children. The dose will be calculated by age or height depending on the child's age Both dosing cups and syringes will be used to administer treatment. For children too young to drink out of a dosing cup, a 1 ml or 5 ml syringe will be used, and the calculated dose will be rounded upwards to the nearest 0.2 ml.",[9,15,19],[29],"Zithromax",[31],{"name":32,"affiliation":5,"role":33},"Kieran S O'Brien, PhD","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Andrea R Picariello, MPH","CONTACT","609-865-4532",null,"andrea.picariello@ucsf.edu",{"name":42,"role":37,"phone":39,"phoneExt":39,"email":43},"Elodie Lebas","elodie.lebas@ucsf.edu",[45],{"facility":46,"status":47,"city":48,"state":39,"zip":39,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Program National de Santé Oculaire","RECRUITING","Niamey","Niger","NE",{"type":52,"coordinates":53},"Point",[54,55],2.1098,13.51366,{"lat":55,"lon":54},[58,62],{"name":59,"role":37,"phone":60,"phoneExt":39,"email":61},"Amza Abdou, MD","+011 227-96-96-16-96","dr.amzaabdou@gmail.com",{"name":63,"role":37,"phone":39,"phoneExt":39,"email":64},"Ahmed Arzika","mamaneahmed@yahoo.fr",{"type":66,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[68,71,73,75,77],{"name":69,"class":70},"Centre de recherche et interventions en santé publique (CRISP)","UNKNOWN",{"name":72,"class":70},"Ministère de la Santé Publique du Niger",{"name":74,"class":70},"Le Programme National de Santé Oculaire",{"name":76,"class":6},"Centre de Recherche Médicale et Sanitaire",{"name":78,"class":6},"Bill and Melinda Gates Foundation","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":92,"type":93},3300000,"ESTIMATED","INTERVENTIONAL",[96],"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.",[99,100],"Mortality","Antimicrobial Resistance",[102,103,104,100,105],"Mass Treatment","Azithromycin","Childhood Mortality Rate","Implementation and Cost Analysis","2025-06-18",{"date":108,"type":109},"2025-06-22","ACTUAL",{"date":111,"type":109},"2024-04-29",{"date":113,"type":93},"2028-04-29",{"name":5,"class":6},1]