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Azithromycin for Child Survival in Niger: Delivery Trial

NCT04774991 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10925

Last updated 2025-04-24

No results posted yet for this study

Summary

This cluster-randomized trial aims to compare the impact of different delivery approaches to azithromycin distribution on coverage, costs, and feasibility outcomes. The investigators hypothesize that door-to-door delivery will have higher coverage and costs and similar feasibility and acceptability compared to fixed-point delivery.

Conditions

  • Mortality
  • Child Health
  • Implementation

Interventions

DRUG

Azithromycin for Oral Suspension

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

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger

    collaborator UNKNOWN

  • University of California, San Francisco

    lead OTHER

Principal Investigators

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

  • Kieran S O'Brien, PhD, MPH · 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
2021-06-28
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • Niger

Study Locations

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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 NCT04774991 on ClinicalTrials.gov