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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:

• Has a new diagnosis of latent RHD detected through primary or secondary school echocardiographic screening.

• Has agreed to participate in the study via the study's informed consent/assent process.

⁃ Operational Definition of Latent RHD Borderline RHD or Mild Definite RHD (to include no more than mild regurgitation at the mitral or aortic valve, normal mean mitral and aortic valve gradients, normal bi-ventricular function) according to the 2012 WHF consensus criteria.

Locations
Other Locations
Uganda
Uganda Heart Institute
RECRUITING
Kampala
Contact Information
Primary
Ndate Fall, MS RN
ndate.fall@cchmc.org
15135171327
Backup
Mary Banks
mary.Banks@cchmc.org
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 1004
Treatments
Experimental: Oral Pencillin
Oral phenoxymethyl penicillin (Pen V) prophylaxis 250mg twice daily.
Active_comparator: IM Penicillin
Intramuscular benzathine benzylpenicillin G (BPG) prophylaxis (600,000 IU for children \<30kg, 1.2 million IU for children ≥30kg), every 28 days
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati
Collaborators: Uganda Heart Institute

This content was sourced from clinicaltrials.gov