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Penicillin break: major trial tests if kids with mild RHD can ditch daily antibiotics

NCT ID NCT07146048

Disease control 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial will test whether children and teens with mild rheumatic heart disease (RHD) can safely stop taking long-term penicillin. About 922 participants aged 5-20 who have stable or normalized RHD after at least 2 years of antibiotics will be randomly assigned to either continue or stop penicillin. Researchers will track if their heart condition gets worse over 2 years using echocardiograms.

What this could mean

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

Active substance
penicillin (antibiotic prophylaxis)
What this could lead to
If successful, this could show that some children with mild rheumatic heart disease can safely stop long-term penicillin without their heart condition getting worse.
What could go wrong
This is a non-inferiority trial, so it is designed to show that stopping is not worse than continuing. Even if it succeeds, the results may only apply to children with very mild or normalized disease, and longer follow-up may reveal risks.

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 922 people

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

Started

Mar 2026

Expected to finish

Dec 2029

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 20 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Participated in GOALIE * Concluded GOALIE with either echocardiographic normalization or stable mild RHD * Between ages 5-20 years at time of enrollment Exclusion Criteria: * RHD Stage C/D at GOALIE end of study echocardiogram * Relocation to extremely distant residence or school * Clinically documented penicillin allergy

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Conditions

The condition(s) this trial relates to.

rheumatic heart disease

As listed by the trial registrant

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

Rheumatic heart disease

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

    RECRUITING

    Kampala, UG, Uganda

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