NCT05288023

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

Azithromycine Pour la Vie Des Enfants au Niger - Implémentation et Recherche: Essai mortalité et résistance (Azithromycin for Child Survival in Niger: Programmatic Trial)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 169,707 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 1 Month
• Healthy volunteers: Accepted

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.

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 azithromycin administration to children aged 1-11 months distributed by community health workers or 2) no intervention: no distribution of azithromycin. A total of 2,490 communities within selected CSIs will be included . All communities in both arms receive routine health services offered by community health workers working for the Niger Ministry of Health's community health program. Mortality will be monitored through birth histories. Mortality and morbidity will also be monitored using routinely collected community and clinic visit data. Antimicrobial resistance will be monitored in a subset of eligible CSIs.

Conditions

• Resistance Bacterial
• Morality
• Child Health
• Implementation

Interventions

Type	Name	Description
DRUG	Azithromycin for Oral Suspension	Azithromycin will be administered as a single dose in oral suspension form for children (up to the maximum adult dose of 1g). Dosage will be calculated by age for children aged 1-5 months. For children 6-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program.

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-01-15
• Completion: 2024-01-15
• First posted: 2022-03-18
• Last updated: 2025-03-28
• Results posted: 2025-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study