Actively Recruiting

Phase 4
Age: 1Month - 59Months
All Genders
Healthy Volunteers
NCT06358872

Azithromycin for Child Survival in Niger II

Led by University of California, San Francisco · Updated on 2025-06-22

3300000

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

C

Centre de recherche et interventions en santé publique (CRISP)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Azithromycin for Child Survival in Niger II

Who Can Participate

Age: 1Month - 59Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Located in a region participating in the program
  • Designated as rural by local study team
  • Selected for participation in monitoring activities
  • Safe and accessible for study teams
  • Verbal approval from community leaders
  • Residing in the catchment area of an eligible CSI
  • Selected for participation in monitoring activities
  • Female aged between 12 and 55 years old
  • Verbal approval from participant
  • Residing in the catchment area of an eligible CSI
  • Selected for participation in monitoring activities
  • Child aged between 1 and 59 months old
  • Verbal approval from a caregiver or guardian
Not Eligible

You will not qualify if you...

  • Designated as urban by local study team
  • Inaccessible or unsafe for study team
  • Known allergy to macrolides

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Program National de Santé Oculaire

Niamey, Niger

Actively Recruiting

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Research Team

A

Andrea R Picariello, MPH

CONTACT

E

Elodie Lebas

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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