CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 864,493 enrolled
Drug / intervention
Azithromycin +1 moredrug
Likely dose
Azithromycin 20mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04224987
NCT04224987Phase 4Completed

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

University of California, San Francisco·interventional·Posted Jan 13, 2020·Updated May 14, 2025

In Brief

A Phase 4 clinical trial evaluating Azithromycin and Placebo for Mortality and 2 related conditions. Completed, enrolled 864,493 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNiger

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJan 13, 2020
Enrollment StartNov 24, 2020
Primary CompletionJul 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.5 years ago

Interventions

Azithromycindrug

Azithromycin will be administered as a directly observed dose in oral suspension form for children: 1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g) 2. For children 1-11 months of age, weight or age-based dosing will be used 3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program

Placeboother

Placebo will be administered as a directly observed dose in oral suspension form for children: 1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g) 2. For children 1-11 months of age, weight-based dosing will be used 3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program