Status:
UNKNOWN
Determining the Impact of Penicillin in Latent RHD: The GOAL Trial
Lead Sponsor:
Children's National Research Institute
Collaborating Sponsors:
Thrasher Research Fund
University of Cape Town
Conditions:
Rheumatic Heart Disease in Children
Latent Rheumatic Heart Disease
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
Brief Summary
Rheumatic heart disease (RHD) affects at least 32.9 million people, mostly children living in low-resource settings. Long-term intramuscular benzathine penicillin G (BPG) prophylaxis is proven to prev...
Eligibility Criteria
Inclusion
- Children will be eligible for study participation if they are (1) between the ages of 5-17 years and (2) have a new diagnosis of latent RHD detected through primary school echo screening and confirmed by blinded consensus review. All children will be recruited from schools in Gulu District in Uganda.
Exclusion
- Patients will be excluded from the study for the following reasons:
- Known history of ARF or RHD
- Newly diagnosed RHD by echo screening consider 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 ≥ 5mmHg) (WHF, definite B), 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).
- Prior allergic reaction to penicillin
- Any known conditions predisposing to thrombocytopenia or hypercoagulability, or other contraindications to intramuscular injection
- Any known co-morbid conditions (HIV, renal deficiencies, severe malnutrition among others) that have resulted in prescription of regular antibiotic prophylaxis
Key Trial Info
Start Date :
June 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
807 Patients enrolled
Trial Details
Trial ID
NCT03346525
Start Date
June 26 2018
End Date
November 30 2020
Last Update
October 1 2019
Active Locations (1)
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1
GOAL Office
Gulu, Uganda, 20010