Status:
TERMINATED
Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Ministry of Health, Niger
Conditions:
Resistance Bacterial
Morality
Eligibility:
All Genders
1+ years
Phase:
PHASE4
Brief Summary
The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this inte...
Detailed Description
In the Programmatic Trial, community health centers (also known as "CSIs" or "Centres de Santé Intégrés") will be randomized to one of two arms: 1) programmatic azithro 1-11: biannual oral azithromyci...
Eligibility Criteria
Inclusion
- Intervention
- At the community-level, eligibility includes:
- Inclusion Criteria:
- Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions
- Distinguishable from neighboring communities
- Verbal consent of community leader(s)
- Exclusion criteria:
- Inaccessible or unsafe for study team
- "Quartier" designation on national census
- At the individual-level, eligibility includes:
- Inclusion criteria:
- Age 1-11 months
- Primary residence in a study community
- Verbal consent of caregiver/guardian for study participation
- Exclusion criteria:
- Known allergy to macrolides
- Population-based sample collections
- At the community-level, eligibility includes:
- Inclusion criteria:
- Location in study region
- Distinguishable from neighboring communities
- Verbal consent of community leader(s)
- Exclusion criteria:
- Inaccessible or unsafe for study team
- Included in MORDOR trials
- Not randomly selected
- At the individual-level, eligibility includes:
- Inclusion criteria:
- Age 1-59 months or 7-12 years or caregiver/guardian of a child eligible for treatment
- Primary residence in a study community selected for sample collections
- Verbal consent of caregiver/guardian for study participation
- Exclusion criteria:
- Not on list of randomly selected participants from the census
Exclusion
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2024
Estimated Enrollment :
169707 Patients enrolled
Trial Details
Trial ID
NCT05288023
Start Date
December 1 2022
End Date
January 15 2024
Last Update
March 28 2025
Active Locations (1)
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1
Proctor foundation
San Francisco, California, United States, 94143