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

  • Time Stamp: March 31, 2024
  • Source Node: 154760

Studies

Study First Submitted Date 2023-01-04
Study First Posted Date 2023-01-23
Last Update Posted Date 2023-05-08
Start Month Year April 1, 2024
Primary Completion Month Year March 31, 2027
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-05-08

Detailed Descriptions

Sequence: 20718240
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.

Facilities

Sequence: 200070871
Name Uganda Heart Institute
City Kampala
Country Uganda

Facility Contacts

Sequence: 28099187
Facility Id 200070871
Contact Type primary
Name Emmy H Okello
Email emmyoks@gmail.com
Phone +256775522284

Browse Interventions

Sequence: 96035961 Sequence: 96035962 Sequence: 96035963 Sequence: 96035964 Sequence: 96035965 Sequence: 96035966 Sequence: 96035967
Mesh Term Penicillins Mesh Term Penicillin G Mesh Term Penicillin G Benzathine Mesh Term Penicillin G Procaine Mesh Term Penicillin V Mesh Term Anti-Bacterial Agents Mesh Term Anti-Infective Agents
Downcase Mesh Term penicillins Downcase Mesh Term penicillin g Downcase Mesh Term penicillin g benzathine Downcase Mesh Term penicillin g procaine Downcase Mesh Term penicillin v Downcase Mesh Term anti-bacterial agents Downcase Mesh Term anti-infective agents
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Conditions

Sequence: 52161520
Name Rheumatic Heart Disease
Downcase Name rheumatic heart disease

Id Information

Sequence: 40151945
Id Source org_study_id
Id Value 2022-0892

Countries

Sequence: 42561236
Name Uganda
Removed False

Design Groups

Sequence: 55583633 Sequence: 55583634
Group Type Experimental Group Type Active Comparator
Title Oral Pencillin Title IM Penicillin
Description Oral phenoxymethyl penicillin (Pen V) prophylaxis 250mg twice daily. Description Intramuscular benzathine benzylpenicillin G (BPG) prophylaxis (600,000 IU for children <30kg, 1.2 million IU for children ≥30kg), every 28 days

Interventions

Sequence: 52476897 Sequence: 52476898
Intervention Type Drug Intervention Type Drug
Name phenoxymethyl penicillin Name intramuscular benzathine penicillin G (BPG) prophylaxis
Description Prophylaxis Description Prophylaxis

Design Outcomes

Sequence: 177345379 Sequence: 177345380 Sequence: 177345381 Sequence: 177345382 Sequence: 177345383 Sequence: 177345384 Sequence: 177345385
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Progression Measure Demonstrate non-inferior costs and cost-effectiveness of oral penicillin compared to IM penicillin Measure Obtain cost data associated with the receipt of oral or IM penicillin in the community from a healthcare provider perspective. Measure Treatment Acceptance Measure Treatment Satisfaction Measure Health-Related Quality of Life Measure Patient-reported outcomes
Time Frame 2 year endpoint Time Frame baseline, 6, 12, 18, 24 months post randomization Time Frame 2 year endpoint Time Frame baseline, 6, 12, 18, 24 months post randomization Time Frame baseline, 6, 12, 18, 24 months post randomization Time Frame baseline, 6, 12, 18, 24 months post randomization Time Frame baseline, 6, 12, 18, 24 months post randomization
Description Progression of echocardiographic features of latent RHD to borderline to definite, or definite to mild or definite to moderate/severe Description The aim is to understand the costs and effectiveness of the intervention. Costs will include intervention and disease specific costs, capturing both health system and family out of pocket costs. Participants will complete a questionnaire asking about out-of-pocket cost (medications, supplies, consultation fees) and lost productivity (including missed school and workdays) due to the intervention. Costs will be measured in the local currency (Uganda Shillings) and presented in United States dollars (USD) Description In order to understand health center and community costs, 10 randomly selected health care facilities (including level II, III, and IV facilities) will be surveyed to obtain direct costs of medications, supplies as well as any administration and professional fees associated with outpatient and inpatient visits. Description Treatment acceptance will be assessed with the widely-used Chronic Treatment Acceptance (ACCEPT) questionnaire, a generic medication acceptance instrument validated for chronic conditions. This 25-item survey consists of six areas of focus: medication convenience (3 items), length of treatment (2 items), medication constraints (9 items), medication side effects (5 items), medication effectiveness (3 items), medication advantages (3 items). Responses are rated on a 5-point Likert scale and scores of 1 through 4 indicating increasing levels of acceptance. Description Treatment Satisfaction will be assessed with the 14-item Abbreviated Treatment Satisfaction Questionnaire (v 1.4). This widely used survey contains 4 areas of focus including satisfaction of treatment effectiveness (3 items), satisfaction with treatment side effects (5 items), satisfaction with treatment convenience (3 items), and a global treatment satisfaction (3 items). Scores are then transformed to a score of 0-100 to create the overall scale score and the subcategory scores, with higher scores representing higher treatment satisfaction on that domain. Description Health Related Quality of Life will be measured using the Pediatric Quality of Life Inventory Version 4.0 Generic Core (PedsQL 4.0) questionnaire. The PedsQLTM4.0 is a 23-item survey for children aged 5-18 which assesses HRQOL. It has four areas of focus: Physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), school functioning (5 items). Each item has five possible responses measuring the extent to which the item was a problem during the past month. The possible responses are measured using a 5-point Likert scale from 0=never a problem to 4 = almost always a problem. These reverse scaled scores are then transformed to a score of 0-100 to create the overall scaled score and the subcategory scores, with higher scores representing better quality of life. Description Interviews will be used to collect qualitative data around participants perceptions of the impact of RHD and its treatment on their activities of daily living and quality of life including experiences with IM or oral penicillin prophylaxis.

Browse Conditions

Sequence: 193451646 Sequence: 193451647 Sequence: 193451648 Sequence: 193451649 Sequence: 193451650 Sequence: 193451651 Sequence: 193451652 Sequence: 193451653 Sequence: 193451654 Sequence: 193451655 Sequence: 193451656 Sequence: 193451657
Mesh Term Rheumatic Heart Disease Mesh Term Rheumatic Diseases Mesh Term Heart Diseases Mesh Term Cardiovascular Diseases Mesh Term Musculoskeletal Diseases Mesh Term Connective Tissue Diseases Mesh Term Rheumatic Fever Mesh Term Streptococcal Infections Mesh Term Gram-Positive Bacterial Infections Mesh Term Bacterial Infections Mesh Term Bacterial Infections and Mycoses Mesh Term Infections
Downcase Mesh Term rheumatic heart disease Downcase Mesh Term rheumatic diseases Downcase Mesh Term heart diseases Downcase Mesh Term cardiovascular diseases Downcase Mesh Term musculoskeletal diseases Downcase Mesh Term connective tissue diseases Downcase Mesh Term rheumatic fever Downcase Mesh Term streptococcal infections Downcase Mesh Term gram-positive bacterial infections Downcase Mesh Term bacterial infections Downcase Mesh Term bacterial infections and mycoses Downcase Mesh Term infections
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48310897 Sequence: 48310898
Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Children's Hospital Medical Center, Cincinnati Name Uganda Heart Institute

Overall Officials

Sequence: 29280699
Role Principal Investigator
Name Andrea Z Beaton
Affiliation Cincinnati Chidren's hospital

Central Contacts

Sequence: 12006034 Sequence: 12006035
Contact Type primary Contact Type backup
Name Ndate Fall, MS RN Name Mary Banks
Phone 15135171327
Email ndate.fall@cchmc.org Email mary.Banks@cchmc.org
Role Contact Role Contact

Design Group Interventions

Sequence: 68137455 Sequence: 68137456
Design Group Id 55583633 Design Group Id 55583634
Intervention Id 52476897 Intervention Id 52476898

Eligibilities

Sequence: 30760339
Gender All
Minimum Age 5 Years
Maximum Age 17 Years
Healthy Volunteers No
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)
Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254261870
Number Of Facilities 1
Registered In Calendar Year 2023
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 5
Maximum Age Num 17
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 6

Designs

Sequence: 30506543
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26668216 Sequence: 26668217
Intervention Id 52476897 Intervention Id 52476898
Name Pen V Name benzathine penicillin G, BPG, penicillin prophylaxis

Responsible Parties

Sequence: 28872819
Responsible Party Type Sponsor
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