Status:
NOT_YET_RECRUITING
A Non-Inferiority Trial of Stopping Penicillin in Early Rheumatic Heart Disease: GOAL-Stop
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Uganda Heart Institute
Open Philanthropy
Conditions:
Rheumatic Heart Disease
Eligibility:
All Genders
5-20 years
Phase:
PHASE3
Brief Summary
GOAL-Stop is a randomized, controlled, non-inferiority trial designed to evaluate whether discontinuing secondary antibiotic prophylaxis (SAP) is non-inferior to continuing SAP in preventing progressi...
Eligibility Criteria
Inclusion
- Participated in GOALIE
- Concluded GOALIE with either echocardiographic normalization or stable mild RHD
- Between ages 5-20 years at time of enrollment
Exclusion
- RHD Stage C/D at GOALIE end of study echocardiogram
- Relocation to extremely distant residence or school
- Clinically documented penicillin allergy
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
922 Patients enrolled
Trial Details
Trial ID
NCT07146048
Start Date
February 1 2026
End Date
December 31 2029
Last Update
December 18 2025
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