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.
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
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
Parallel
Oral Penicillin V
DrugTwice-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.
Cumulative Incidence of RHD at One Year
Proportion of participants with newly diagnosed rheumatic heart disease based on blinded echocardiographic adjudication.
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.
Cumulative Incidence of RHD at Two Years
Proportion of participants with newly diagnosed rheumatic heart disease based on blinded echocardiographic adjudication.
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.
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Children's Hospital Medical Center, Cincinnati
Lead sponsor
The University of Western Australia
Collaborator
Uganda Heart Institute
Collaborator
Ochsner Health System
Collaborator
Murdoch Childrens Research Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
