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ACTIVE NOT RECRUITING
NCT05693545
PHASE2

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

Sponsor: Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

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.

Official title: Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent Rheumatic Heart Disease: A Non-inferiority Randomized Trial

Key Details

Gender

All

Age Range

5 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

1004

Start Date

2023-09-01

Completion Date

2027-09-30

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

DRUG

phenoxymethyl penicillin

Prophylaxis

DRUG

intramuscular benzathine penicillin G (BPG) prophylaxis

Prophylaxis

Locations (1)

Uganda Heart Institute

Kampala, Uganda, Uganda