drugset / Trial / NCT05693545
GOALIE: Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent RHD Trial
Phase 2
Active not recruiting
1004 enrolled
Children's Hospital Medical Center, Cincinnati
Uganda Heart Institute · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |