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NCT07798232
Penicillin to Prevent Early Rheumatic Heart Disease in School-Aged Children
Conditions: Rheumatic Heart Disease in Children
Sex: All
Ages: 5 Years – 8 Years
Healthy volunteers: Yes
Phase: PHASE3
Enrollment: 9622
Sponsor: Children's Hospital Medical Center, Cincinnati
Location: Uganda Heart Institute Kampala Uganda
Summary
This study will look at whether children ages 5-8 who take Penicillin V by mouth twice a day are less likely to develop rheumatic heart disease (RHD) over a 3-year period compared to children who do not take the medicine.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07798232). StuddyBuddy aggregates publicly available trial information.