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

NCT05288023 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 169707

Last updated 2025-03-28

Study results available
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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.

Conditions

  • Resistance Bacterial
  • Morality
  • Child Health
  • Implementation

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Kieran O'Brien, PhD, MPH · University of California, San Francisco

  • Tom Lietman, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-01-15
Completion
2024-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05288023 on ClinicalTrials.gov