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A simple antibiotic may shield children from heart disease

NCT ID NCT07798232

Prevention Sponsor: Children's Hospital Medical Center, Cincinnati 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This trial tests whether giving children aged 5 to 8 a twice-daily penicillin pill can prevent rheumatic heart disease, a serious condition that can damage heart valves. Researchers will compare children who take the antibiotic with those who do not, following them for three years. The study uses heart ultrasounds to check for new cases of the disease.

What this could mean

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

Active substance
Penicillin V (an antibiotic) taken by mouth twice a day
What this could lead to
If it works, this could offer a simple, low-cost way to prevent rheumatic heart disease in children, saving many from a serious heart condition.
What could go wrong
The trial is large but still early in its timeline, and results may not show a clear benefit. Penicillin can cause allergic reactions, and some children may not take the medicine as prescribed.

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 9,622 people

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

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Mar 2032

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

5 to 8 years

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: * Age 5-8 years at enrollment * Residence within the participating study catchment area (Gulu District or Gulu City) * Normal study echocardiogram confirmed by the expert adjudication panel * Parent/guardian able and willing to provide written informed consent * Participant able to provide written assent (age 8 years) Exclusion Criteria: * History of prior ARF or RHD with or without cardiac involvement * Evidence of RHD on baseline echocardiography * Congenital heart disease (excluding small PFO, small ASD) or other cardiac abnormality at baseline echocardiography * Self-reported known allergy to penicillin * Medical conditions that would preclude safe participation, adherence, or follow-up * Anticipated inability to complete 36 months of study follow-up * Any known co-morbid condition requiring regular antibiotic prophylaxis

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Conditions

The condition(s) this trial relates to.

rheumatic heart disease prevention target

As listed by the trial registrant

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

Rheumatic heart disease in children

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

  • Uganda Heart Institute

    Kampala, Uganda, Uganda

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