Overview

Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR)

Status:
Not yet recruiting
Trial end date:
2026-03-01
Target enrollment:
0
Participant gender:
All
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 intervention, which include targeting azithromycin distributions to children 1-11 months of age in high mortality settings. The proposed trial aims to demonstrate and evaluate large-scale implementation of azithromycin to children aged 1-11 months old in the context of a programmatic setting while monitoring mortality and resistance antimicrobial resistance.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
Bill and Melinda Gates Foundation
Ministry of Health, Niger
Treatments:
Azithromycin
Criteria
Intervention

At the community-level, eligibility includes:

Inclusion Criteria:

- Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions

- Population 250 to 2,499*

- Distance > 5 km from district headquarters town

- 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