Azithromycin for Child Survival in Niger II

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-59
SponsorUniversity of California, San Francisco

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

3,300,000 Participants
are divided into 3 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