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COMPLETED
NCT04224987
PHASE4

Azithromycin for Child Survival in Niger: Mortality and Resistance Trial

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

1 Month - 59 Months

Study Type

INTERVENTIONAL

Enrollment

864493

Start Date

2020-11-24

Completion Date

2024-07-31

Last Updated

2026-08-06

Healthy Volunteers

Yes

Interventions

DRUG

Azithromycin

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

OTHER

Placebo

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

Locations (1)

Programme national de santé oculaire

Niamey, Niger