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Mass antibiotic dosing could save thousands of children in niger

NCT ID NCT06358872

Disease control Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This trial investigates whether giving a single dose of azithromycin to children in rural Niger can lower death rates under age five. Over 3 million children are involved, with monitoring of both mortality and antimicrobial resistance. The study adapts every two years to refine the approach and assess long-term effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
azithromycin oral suspension
What this could lead to
If successful, this could provide a scalable strategy to reduce child mortality in rural Niger and similar settings.
What could go wrong
The trial is large but observational in parts, and increased antimicrobial resistance is a known risk that may limit long-term benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 3,300,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 59 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antimicrobial resistance Mortality

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Program National de Santé Oculaire

    RECRUITING

    Niamey, Niger

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