Clinical Trial

Azithromycin for Child Survival in Niger II

Study acronym: AVENIR II
Recruiting Phase 4
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Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-04-08; most recent amendment 2026-07-13.
Status change: Not Yet Recruiting → Recruiting 2024-06-14
Trial Details
NCT Number NCT06358872
Lead Sponsor University of California, San Francisco
Collaborators: Centre de recherche et interventions en santé publique (CRISP), Ministère de la Santé Publique du Niger, Le Programme National de Santé Oculaire, Centre de Recherche Médicale et Sanitaire, Bill and Melinda Gates Foundation
Conditions Mortality, Antimicrobial Resistance
Enrollment 3,300,000 participants
Start Date 2024-04-29
Primary Completion 2028-04-29 (estimated)
Study Completion 2028-04-29 (estimated)
Updated on ClinicalTrials.gov 2026-07-14