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Could a simple antibiotic added to childhood vaccines save thousands of young lives?

NCT ID NCT04235816

Prevention Sponsor: Barcelona Institute for Global Health 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large study in Sierra Leone is testing whether giving children an antibiotic (azithromycin) along with malaria prevention medicine during their regular vaccine visits can lower the number of deaths in children under 5. Over 20,000 children are taking part. The goal is to find a practical way to prevent deadly infections like malaria, pneumonia, and diarrhea.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 20,560 people

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

Started

Mar 2021

Expected to finish

Apr 2026

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

6 to 8 weeks

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: * Parents/guardians have signed the informed consent * Permanent residence in the study area-health facility catchment area * Without known allergies to or contraindications to macrolides * Without known allergies to or contraindications to SP * Agreement to complete the EPI scheme at the recruitment health facility * Parents/guardians agree to participate Exclusion Criteria: * Residence outside the study area or planning to move out in the following 12 months from enrolment * Known history of allergy or contraindications to macrolides and/or SP * Known history of allergy or contraindications to SP * With signs of any acute illness at the time of recruitment * Participating in other intervention studies

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Conditions

The condition(s) this trial relates to.

malaria

As listed by the trial registrant

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

Child mortality

Contacts and locations

Locations

  • College of Medicine and Allied Health Sciences

    Freetown, Sierra Leone

More trials for these conditions

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