protocolSection identificationModule nctId: NCT06358872, orgStudyIdInfo id: 23-39839, briefTitle: Azithromycin for Child Survival in Niger II, acronym: AVENIR II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2028-04-29, completionDateStruct date: 2028-04-29, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: Centre de recherche et interventions en santé publique (CRISP), collaborators name: Ministère de la Santé Publique du Niger, collaborators name: Le Programme National de Santé Oculaire, collaborators name: Centre de Recherche Médicale et Sanitaire, collaborators name: Bill and Melinda Gates Foundation, descriptionModule briefSummary: 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., conditionsModule conditions: Mortality, conditions: Antimicrobial Resistance, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The intervention will involve biannual oral azithromycin MDA to children 1-59 months old distributed by community health workers. The Centre de Santé Integré (CSI) will be randomized to receive azithromycin MDA or delayed treatment in a stepped wedge design for the first 2 years. The delayed intervention arm will receive usual care for the first 2 years, then will receive the intervention for the next 2 years., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants, community health workers delivering the intervention, and team members supervising the program will not be masked. One biostatistician and one data analyst will remain unmasked to prepare the randomization sequence. Masked personnel include outcome assessors as well as the biostatistician and data analyst conducting the data analyses., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 3300000, type: ESTIMATED, armsInterventionsModule interventions name: Azithromycin for Oral Suspension, outcomesModule primaryOutcomes measure: All-cause mortality, primaryOutcomes measure: All-cause mortality, primaryOutcomes measure: Prevalence of resistance to macrolides - nasopharyngeal swabs, primaryOutcomes measure: Prevalence of resistance to macrolides - nasopharyngeal swabs, primaryOutcomes measure: Load of genetic determinants of resistance to macrolides - rectal swabs, primaryOutcomes measure: Load of genetic determinants of resistance to macrolides - rectal swabs, secondaryOutcomes measure: Number of clinic visits - infectious, secondaryOutcomes measure: Number of clinic visits - infectious, secondaryOutcomes measure: Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs, secondaryOutcomes measure: Prevalence of Genetic Determinants of resistance - Nasopharyngeal swabs, secondaryOutcomes measure: Program Cost Per Dose Delivered, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 59 Months, stdAges: CHILD, contactsLocationsModule locations facility: Program National de Santé Oculaire, city: Niamey, country: Niger, geoPoint lat: 13.51366, lon: 2.1098, hasResults: False