About this trial
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.
Eligibility criteria
Qualifiers
Located in a region participating in the program
Designated as rural by local study team
Selected for participation in monitoring activities
Safe and accessible for study teams
Disqualifiers
Designated as urban by local study team
Inaccessible or unsafe for study team
Known allergy to macrolides
Trial design
Treatments tested in this trial
- Azithromycin for Oral Suspension
Treatment groups
Sponsors and collaborators
University of California, San Francisco
Lead sponsor
Centre de recherche et interventions en santé publique (CRISP)
Collaborator
Ministère de la Santé Publique du Niger
Collaborator
Le Programme National de Santé Oculaire
Collaborator
Centre de Recherche Médicale et Sanitaire
Collaborator
Bill and Melinda Gates Foundation
Collaborator