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Azithromycin for Child Survival in Niger II

NCT06358872 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3300000

Last updated 2025-06-22

No results posted yet for this study

Summary

Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years.

Conditions

Interventions

DRUG

Azithromycin for Oral Suspension

Azithromycin will be administered as a single dose, in oral suspension form for children. The dose will be calculated by age or height depending on the child's age Both dosing cups and syringes will be used to administer treatment. For children too young to drink out of a dosing cup, a 1 ml or 5 ml syringe will be used, and the calculated dose will be rounded upwards to the nearest 0.2 ml.

Sponsors & Collaborators

  • Centre de recherche et interventions en santé publique (CRISP)

    collaborator UNKNOWN

  • Ministère de la Santé Publique du Niger

    collaborator UNKNOWN

  • Le Programme National de Santé Oculaire

    collaborator UNKNOWN

  • Centre de Recherche Médicale et Sanitaire

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2028-04-29
Completion
2028-04-29
FDA Drug
Yes

Countries

  • Niger

Study Locations

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Entities

Diseases
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 NCT06358872 on ClinicalTrials.gov