Azithromycin for Child Survival in Niger II
Recruiting now · Phase 4
Conditions studied: Mortality, Antimicrobial Resistance
In brief
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.
Key facts
- Study ID
- NCT06358872
- Run by
- University of California, San Francisco
- People needed
- 3300000
- Starts
- 2024-04-29
- Expected to finish
- 2028-04-29
- Last updated by the study team
- 2026-07-14
Who can join
Age: 0 and older, up to 5. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- CSI-level for mortality and AMR monitoring:
- 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
- Verbal approval from community leaders
- Individual level for mortality monitoring:
- Residing in the catchment area of an eligible CSI
- Selected for participation in monitoring activities
- Female
- Age between 12 and 55 years old
- Verbal approval from participant
- Individual-level for AMR monitoring:
- Residing in the catchment area of an eligible CSI
- Selected for participation in monitoring activities
- Age between 1 and 59 months old
- Verbal approval from a caregiver or guardian
You may not qualify if…
- At the community-level:
- Designated as urban by local study team
- Inaccessible or unsafe for study team
- At the individual-level:
- Known allergy to macrolides
Where it is running
- Program National de Santé Oculaire — Niamey, Niger (enrolling)
Full record on ClinicalTrials.gov
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