A Phase 3 interventional study of Oral Penicillin V in Rheumatic Heart Disease in Children, sponsored by Children's Hospital Medical Center, Cincinnati. Not yet recruiting at 1 site in Uganda. Open to participants aged 5 Years to 8 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 3, Interventional, and Prevention
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.
Exclusion Criteria:
Drug: Oral Penicillin V
Twice-daily oral Pen V 250 mg
Cumulative Incidence of Rheumatic Heart Disease
Proportion of participants with newly diagnosed RHD based on blinded echocardiographic adjudication among children with a normal baseline echocardiogram.
Time frame: 3 years
Cumulative Incidence of RHD at One Year
Proportion of participants with newly diagnosed rheumatic heart disease based on blinded echocardiographic adjudication.
Time frame: 1 year
Number of Participants who Develop Acute Rheumatic Fever
Percentage of participants who develop acute rheumatic fever (ARF) diagnosed according to the 2015 Revised Jones Criteria among participants in each study arm.
Time frame: 3 years
Cumulative Incidence of RHD at Two Years
Proportion of participants with newly diagnosed rheumatic heart disease based on blinded echocardiographic adjudication.
Time frame: 2 years
Number of Participants who Develop Early RHD
Proportion of participants who develop Stage A or Stage B rheumatic heart disease as determined by blinded echocardiographic adjudication.
Time frame: 3 years
Number of Participants who Develop Advanced RHD
Proportion of participants who develop Stage C or Stage D rheumatic heart disease as determined by blinded echocardiographic adjudication.
Time frame: 3 years
Number of Participants Experiencing Treatment-Emergent Adverse Events
Number and proportion of participants experiencing treatment-emergent adverse events, serious adverse events, treatment discontinuations, or other safety-related events attributable to oral Penicillin V.
Time frame: 3 years
Number of Participants Achieving at least 80% Adherence to Oral Penicillin V Prophylaxis Based on Pill Count
Proportion of participants assigned to Arm 2 who achieve ≥80% adherence to prescribed oral Penicillin V prophylaxis, as assessed by pill count. At each bimonthly school-based visit, remaining tablets will be counted and adherence calculated as the proportion of prescribed doses taken during the assessment interval.
Time frame: 3 years
Number of Participants Achieving at Least 80% Adherence to Oral Penicillin V Prophylaxis Based on DoseSmart® Bottle Opening Records
Proportion of participants assigned to Arm 2 who achieve ≥80% adherence to prescribed oral Penicillin V prophylaxis, as assessed using DoseSmart® electronic bottle opening data downloaded at each bi-monthly visit. Adherence will be calculated as the proportion of expected dosing events recorded over the assessment interval.
Time frame: 3 years
Number of Participants Achieving at Least 80% Adherence to Oral Penicillin V Prophylaxis Based on Caregiver-Reported Dosing Diary
Proportion of participants assigned to Arm 2 who achieve ≥80% adherence to prescribed oral Penicillin V prophylaxis, as assessed using a participant/parent paper diary in which caregivers record each administered dose. Adherence will be calculated as the proportion of prescribed doses documented as taken during the assessment interval.
Time frame: 3 years
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati