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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07798232). StuddyBuddy aggregates publicly available trial information.