Azithromycin for Child Survival in Niger: Mortality and Resistance Trial

• Status: 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.Targeting treatment to children 1-11 months old could reduce antimicrobial resistance by limiting antibiotic distributions while treating children at the highest mortality risk. However, this targeted intervention has not yet been tested.

The AVENIR mortality/resistance trial aims to assess the efficacy of age-based targeting of biannual azithromycin distribution on mortality as well as determine the impact of age-based targeting on 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; Helen Keller International; Ministry of Health, Niger
• Treatments: Azithromycin

Criteria

1. 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 *Population size as estimated from the most recent national census or projections

At the individual-level, eligibility includes:

Inclusion criteria:

• Age 1-59 months

• Primary residence in a study community

• Verbal consent of caregiver/guardian for study participation

• Weight ≥ 3.0 kg

Exclusion criteria:

• Known allergy to macrolides

2. Population-based sample collections

At the community-level, eligibility includes:

Inclusion Criteria:

• Location in Dosso

• Distinguishable from neighboring communities

• Verbal consent of community leader(s)

Exclusion criteria:

• Inaccessible or unsafe for the study team

• Included in MORDOR trials

• Not randomly selected

• Received treatment prior to sample collection

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:

• An individual is not on the list of randomly selected participants from the census