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RECRUITING
NCT06358872
PHASE4

Azithromycin for Child Survival in Niger II

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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.

Official title: Azithromycine Pour la Vie Des Enfants au Niger II

Key Details

Gender

All

Age Range

1 Month - 59 Months

Study Type

INTERVENTIONAL

Enrollment

3300000

Start Date

2024-04-29

Completion Date

2028-04-29

Last Updated

2025-06-22

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Program National de Santé Oculaire

Niamey, Niger