drugset / Trial / NCT05693545

GOALIE: Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent RHD Trial

NCT05693545

RandomizedParallel-groupSingle-blindTreatment

Summary

The goal of this clinical trial is to determine if twice daily oral penicillin prophylaxis is non-inferior to monthly IM penicillin prophylaxis in preventing latent Rheumatic Heart Disease Progression in children between the ages of 5-17 years. The main objective is to compare the proportion of children aged 5-17 years with latent RHD receiving oral penicillin prophylaxis who progress to worse valvular disease at 2-years compared to children who receive IM penicillin prophylaxis.

Timeline

Start
2023-09-01
Primary completion
2027-03-31
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Benzathine Penicillin G Unknown 600000 iu Intramuscular
Comparator Benzathine Penicillin G Unknown 1.2e+06 iu Intramuscular
Subject Penicillin V Small molecule 250 mg Oral