NCT06358872

Azithromycin for Child Survival in Niger II

Azithromycine Pour la Vie Des Enfants au Niger II

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,300,000 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 1 Month – 59 Months
• Healthy volunteers: Accepted

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.

Detailed description

AVENIR II is a cluster-randomized adaptive platform trial designed to evaluate community health interventions in Niger. The initial focus is to monitor under-5 mortality and antimicrobial resistance as the azithromycin MDA for child survival program expands in Niger, with the following specific aims: 1. Mortality. 1. To conduct surveillance of mortality over time compared to the Sustainable Development Goal targets for under-5 mortality reduction. As this intervention is not intended to continue indefinitely, surveillance against a target is needed to determine when to stop. 2. To continue to evaluate the effectiveness of azithromycin MDA to reduce under-5 mortality. Given the risk of AMR, the effectiveness of the intervention over time is needed to fully weigh the risks against the benefits. 2. Antimicrobial Resistance. To determine the impact of azithromycin MDA on AMR in population- and clinic-based samples.

Conditions

• Mortality
• Antimicrobial Resistance

Interventions

Type	Name	Description
DRUG	Azithromycin for Oral Suspension	Azithromycin will be administered as a single dose, in oral suspension form for children. The dose will be calculated by age or height depending on the child's age Both dosing cups and syringes will be used to administer treatment. For children too young to drink out of a dosing cup, a 1 ml or 5 ml syringe will be used, and the calculated dose will be rounded upwards to the nearest 0.2 ml.

Timeline

• Start date: 2024-04-29
• Primary completion: 2028-04-29
• Completion: 2028-04-29
• First posted: 2024-04-11
• Last updated: 2025-06-22

Locations

1 site across 1 country: Niger

Regulatory

• FDA-regulated drug study