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Can a single antibiotic dose cut child mortality in niger?

NCT ID NCT04224987

Prevention 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial tests whether giving azithromycin—a common antibiotic—twice a year to young children in Niger can reduce deaths. It compares giving the drug to all children aged 1-59 months versus only to infants 1-11 months, who are at highest risk. The study also checks how these approaches affect antibiotic resistance. If targeting infants works, it could save lives while reducing the spread of resistant bacteria.

What this could mean

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

Active substance
azithromycin (an antibiotic)
What this could lead to
If successful, this could support a simple, targeted antibiotic strategy to reduce child deaths in high-mortality regions while limiting antibiotic resistance.
What could go wrong
The trial is large but still a test—results may not confirm benefit, and antibiotic resistance remains a real risk with widespread use.

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

864,493 people

The number who actually took part.

Started

Nov 2020

Finished

Jul 2024

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.

1. Intervention At the community-level, eligibility includes: Inclusion Criteria: * Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions * Population 250 to 2,499\* * Distance \> 5 km from district headquarters town * Distinguishable from neighboring communities * Verbal consent of community leader(s) Exclusion criteria: * Inaccessible or unsafe for study team * "Quartier" designation on national census \*Population size as estimated from the most recent national census or projections At the individual-level, eligibility includes: Inclusion criteria: * Age 1-59 months * Primary residence in a study community * Verbal consent of caregiver/guardian for study participation * Weight ≥ 3.0 kg (\*no weight limits in communities using age-based dosing) Exclusion criteria: • Known allergy to macrolides 2. Population-based sample collections At the community-level, eligibility includes: Inclusion Criteria: * Location in Dosso * Distinguishable from neighboring communities * Verbal consent of community leader(s) Exclusion criteria: * Inaccessible or unsafe for the study team * Included in MORDOR trials * Not randomly selected * Received treatment prior to sample collection At the individual-level, eligibility includes: Inclusion Criteria: * Age 1-59 months or 7-12 years or caregiver/guardian of a child eligible for treatment * Primary residence in a study community selected for sample collections * Verbal consent of caregiver/guardian for study participation Exclusion criteria: • An individual is not on the list of randomly selected participants from the census

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Conditions

The condition(s) this trial relates to.

CHILD syndrome

As listed by the trial registrant

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

Child, only Mortality Resistance bacterial

Contacts and locations

Locations

  • Programme national de santé oculaire

    Niamey, Niger

More trials for these conditions

Other studies related to the condition(s) this trial covers.