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Infant Mortality Reduction by the Mass Administration of Azithromycin

NCT04716712 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 694400

Last updated 2025-03-13

No results posted yet for this study

Summary

This trial will investigate the supplementation of azithromycin distribution to the "Child Health Days" platform in Burkina Faso for child mortality reduction. This distribution will pair door-to-door administration of vitamin A and azithromycin or placebo with acute malnutrition screening among children 1-11 months old.

Conditions

  • Child Mortality

Interventions

DRUG

Azithromycin

Azithromycin is a macrolide-type antibiotic that is used to treat various types of infections. Previous studies in Niger have demonstrated a nearly 18% reduction in all-cause child mortality following biannual mass administration to children 1-59 months.

DRUG

Placebo

Matching identical placebo in packaging, appearance, and taste.

Sponsors & Collaborators

  • Helen Keller International

    collaborator OTHER

  • Centre de Recherche en Sante de Nouna, Burkina Faso

    collaborator OTHER_GOV

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

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

  • Georges Dimithe · Helen Keller International

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
1 Month
Max Age
11 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2025-01-30
Completion
2026-01-30
FDA Drug
Yes

Countries

  • United States
  • Burkina Faso

Study Locations

More Related Trials

Entities

Drugs
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 NCT04716712 on ClinicalTrials.gov