Using azithromycin to reduce child mortality in Niger
Official title: Azithromycine Pour la Vie Des Enfants au Niger II
Run by University of California, San Francisco · NCT06358872 · Data updated 2026-11-12
This study is testing whether giving a common antibiotic called azithromycin to children in Niger can help reduce the number of kids who die before age five while also keeping an eye on any risks of antibiotic resistance.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 1 Month to 59 Months |
| Sex | All |
| Enrollment | 3300000 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (Niamey) |
| Status | Recruiting |
| Started | April 29, 2024 |
| Main results expected | April 29, 2028 |
| Study ends | April 29, 2028 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT06358872 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children aged 1 to 59 months residing in rural areas of Niger participating in the azithromycin program.
✕Probably not a fit
Patients who are urban residents or have known allergies to macrolides may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the impact of mass drug administration of azithromycin on child mortality and antimicrobial resistance in Niger. It is designed as a cluster-randomized adaptive platform trial, which will monitor under-5 mortality rates and the development of antimicrobial resistance over time. The trial will involve community health interventions and will adapt based on ongoing results, with monitoring and re-randomization occurring every two years. The goal is to assess the effectiveness of azithromycin in reducing child mortality while also tracking potential risks associated with increased antimicrobial resistance.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce child mortality rates in Niger while providing insights into managing antimicrobial resistance.
How similar studies have gone: Previous studies have shown that azithromycin mass drug administration can reduce child mortality, but the impact on antimicrobial resistance is still being evaluated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: CSI-level for mortality and AMR monitoring: * 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 Individual level for mortality monitoring: * Residing in the catchment area of an eligible CSI * Selected for participation in monitoring activities * Female * Age between 12 and 55 years old * Verbal approval from participant Individual-level for AMR monitoring: * Residing in the catchment area of an eligible CSI * Selected for participation in monitoring activities * Age between 1 and 59 months old * Verbal approval from a caregiver or guardian Exclusion Criteria: At the community-level: * Designated as urban by local study team * Inaccessible or unsafe for study team At the individual-level: * Known allergy to macrolides
Where it's running
-
Program National de Santé Oculaire
Niamey, Niger Recruiting
Study contacts
- Principal investigator: Kieran S O'Brien, PhD — University of California, San Francisco
- Study coordinator: Andrea R Picariello, MPH
- Email: andrea.picariello@ucsf.edu
- Phone: 609-865-4532
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Rapid, multiplex microbiology–guided antibiotic stewardship in hospitalized adults
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-
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This project will test whether the amount of resistant bacteria in nursing home wastewater can indicate how many residents carry those bacteria.
-
Monitoring antimicrobial resistance in pneumonia patients using metagenomics
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.