Status:
COMPLETED
Azithromycin for Child Survival in Niger: Delivery Trial
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger
Conditions:
Mortality
Child Health
Eligibility:
All Genders
1+ years
Phase:
PHASE4
Brief Summary
This cluster-randomized trial aims to compare the impact of different delivery approaches to azithromycin distribution on coverage, costs, and feasibility outcomes. The investigators hypothesize that ...
Detailed Description
Azithromycin distribution has been shown to reduce mortality in children 1-59 months. This trial aims to contribute evidence on viable approaches to implementation as high mortality countries consider...
Eligibility Criteria
Inclusion
- At the community-level, eligibility includes:
- Location in one of the 80 Dosso communities randomly selected for the delivery trial
- Population 250 to 2,499\*
- Distance \> 5 km from the district headquarters town
- Verbal consent of community leader(s)
- At the individual-level, eligibility includes:
- Age 1-59 months
- Primary residence in a study community
- Verbal consent of caregiver/guardian for study participation
- Weight ≥ 4 kg
Exclusion
- At the community-level, eligibility includes:
- Inaccessible or unsafe for study team
- "Quartier" designation on national census \*Population size as estimated from the most recent national census or projections
- At the individual-level, eligibility includes:
- • Known allergy to macrolides
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
10925 Patients enrolled
Trial Details
Trial ID
NCT04774991
Start Date
June 28 2021
End Date
June 30 2023
Last Update
April 24 2025
Active Locations (1)
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1
Program National de Santé Oculaire
Niamey, Niger