Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05693545
Status:
RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-01-04
Brief Title:
GOALIE Intramuscular vs Enteral Penicillin Prophylaxis to Prevent Progression of Latent RHD Trial
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Intramuscular vs Enteral Penicillin Prophylaxis to Prevent Progression of Latent Rheumatic Heart Disease A Non-inferiority Randomized Trial
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
GOALIS is a randomized controlled trial developed to provide high quality contemporary evidence on the efficacy of oral penicillin as RHD prophylaxis
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None