GOALIE: Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent RHD Trial
NCT ID: NCT05693545
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
1004 participants
INTERVENTIONAL
2023-09-01
2027-09-30
Brief Summary
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Detailed Description
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Aim 1: 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.
Aim 2: To evaluate the economic equivalence and cost-effectiveness of oral penicillin compared to IM penicillin, after echocardiographic screening for latent RHD detection.
Aim 3: Compare patient-reported outcomes (treatment acceptance, treatment satisfaction, and health-related quality of life) between children receiving oral and IM penicillin prophylaxis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Oral Pencillin
Oral phenoxymethyl penicillin (Pen V) prophylaxis 250mg twice daily.
phenoxymethyl penicillin
Prophylaxis
IM Penicillin
Intramuscular benzathine benzylpenicillin G (BPG) prophylaxis (600,000 IU for children \<30kg, 1.2 million IU for children ≥30kg), every 28 days
intramuscular benzathine penicillin G (BPG) prophylaxis
Prophylaxis
Interventions
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phenoxymethyl penicillin
Prophylaxis
intramuscular benzathine penicillin G (BPG) prophylaxis
Prophylaxis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
5 Years
17 Years
ALL
No
Sponsors
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Uganda Heart Institute
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Andrea Z Beaton
Role: PRINCIPAL_INVESTIGATOR
Cincinnati Chidren's hospital
Locations
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Uganda Heart Institute
Kampala, , Uganda
Countries
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Central Contacts
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Facility Contacts
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Emmy H Okello
Role: primary
References
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Rwebembera J, Ndagire E, Carvalho N, Webel AR, Sable C, Okello E, Sarnacki R, Spaziani AM, Mucunguzi A, Engelman D, Grobler A, Steer A, Beaton A. Intramuscular versus enteral penicillin prophylaxis to prevent progression of rheumatic heart disease: Study protocol for a noninferiority randomized trial (the GOALIE trial). Am Heart J. 2024 Sep;275:74-85. doi: 10.1016/j.ahj.2024.05.012. Epub 2024 May 24.
Other Identifiers
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2022-0892
Identifier Type: -
Identifier Source: org_study_id