Comparing oral and intramuscular penicillin to prevent worsening of latent Rheumatic Heart Disease in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of twice-daily oral penicillin compared to monthly intramuscular penicillin in preventing the progression of latent Rheumatic Heart Disease (RHD) in children aged 5-17 years. It is a randomized controlled trial that will assess the proportion of participants who experience worsening valvular disease over a two-year period. Additionally, the study will analyze the cost-effectiveness of both prophylactic methods and gather patient-reported outcomes regarding treatment acceptance and quality of life. The trial is designed to provide contemporary evidence on the efficacy of oral penicillin as a viable alternative to intramuscular injections.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Has a new diagnosis of latent RHD detected through primary or secondary school echocardiographic screening.
* Has agreed to participate in the study via the study's informed consent/assent process.

Operational Definition of Latent RHD Borderline RHD or Mild Definite RHD (to include no more than mild regurgitation at the mitral or aortic valve, normal mean mitral and aortic valve gradients, normal bi-ventricular function) according to the 2012 WHF consensus criteria.

Exclusion Criteria:

* Known history of ARF or RHD
* Newly diagnosed RHD by echo screening considered to be "missed clinical RHD" as compared to true latent RHD including: \> mild pathological valvular regurgitation at the mitral valve or aortic valve, mitral stenosis (mean MV gradient ≥ 4mmHg) (definite B61), aortic stenosis (mean AV gradient ≥ 20mmHg)
* Structural or functional cardiac defects, other than those consistent with RHD, that were known prior to or detected through echo screening (except patent foramen ovale, small atrial septal defect, small ventricular septal defect, small patent ductus arteriosus)
* Self-report of prior allergic reaction to penicillin
* Any known conditions predisposing to thrombocytopenia or hypercoagulability, or other contraindications to intramuscular injection
* Any known co-morbid conditions (ex. HIV, renal deficiencies, severe malnutrition) that have resulted in prescription of regular antibiotic prophylaxis)

Where it's running

• Uganda Heart Institute
  Kampala, Uganda Recruiting

Study contacts

• Principal investigator: Andrea Z Beaton — Cincinnati Chidren's hospital
• Study coordinator: Ndate Fall, MS RN
• Email: ndate.fall@cchmc.org
• Phone: 15135171327

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.