RecruitingPhase 4NCT06358872

Azithromycin for Child Survival in Niger II

Azithromycine Pour la Vie Des Enfants au Niger II

Sponsor

University of California, San Francisco

Enrollment

3,300,000 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

Mortality

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.

Eligibility

Min Age: 1 MonthMax Age: 59 Months

Inclusion Criteria17

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

Exclusion Criteria5

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

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Interventions

DRUGAzithromycin 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.