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Azithromycin for Child Survival in Niger II

Study acronym: AVENIR II
StatusRecruiting
PhasePhase 4
Started2024-04-29
View on ClinicalTrials.gov ↗

Amendment history

2026-08-13
minor
Study Status, Outcome Measures v5
Secondary endpoints5 to 6 entries
Prevalence of Reported Illness
2026-07-13
minor
2 amendments v3-v4
2 re-verifications since 2025-06-18, no change to tracked fields
2024-06-14
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2024-04-10
minor
Study Status, Outcome Measures, Contacts/Locations v1
Re-verified, no change to tracked fields
2024-04-08
minor
Original filing
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.
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 2026-08-17