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

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Jan 11, 2023

Keywords

ClinConnect Summary

The GOALIE trial is studying how effective two different ways of giving penicillin are at preventing the worsening of Rheumatic Heart Disease (RHD) in children aged 5 to 17 years. Specifically, it compares taking penicillin by mouth twice a day to receiving penicillin through an injection once a month. Researchers want to see if both methods work equally well in preventing the progression of RHD over a period of two years.

To be eligible for this study, children must have recently been diagnosed with a mild form of latent RHD through heart screenings done at school. They also need to agree to participate in the trial with their parent or guardian’s consent. Throughout the study, participants will receive either the oral or injectable penicillin and will be monitored to see how their heart condition develops. It's important to note that children with a history of severe RHD, certain heart defects, or allergies to penicillin cannot participate. This study is currently recruiting participants, and it's an opportunity for families to contribute to important research that could help improve treatment for RHD in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Known history of ARF or RHD
• • Newly diagnosed RHD by echo screening considered to be "missed clinical RHD" as compared to true latent RHD including: \> mild pathological valvular regurgitation at the mitral valve or aortic valve, mitral stenosis (mean MV gradient ≥ 4mmHg) (definite B61), aortic stenosis (mean AV gradient ≥ 20mmHg)
• • Structural or functional cardiac defects, other than those consistent with RHD, that were known prior to or detected through echo screening (except patent foramen ovale, small atrial septal defect, small ventricular septal defect, small patent ductus arteriosus)
• • Self-report of prior allergic reaction to penicillin
• • Any known conditions predisposing to thrombocytopenia or hypercoagulability, or other contraindications to intramuscular injection
• • Any known co-morbid conditions (ex. HIV, renal deficiencies, severe malnutrition) that have resulted in prescription of regular antibiotic prophylaxis)