A Phase 2 interventional study of intramuscular benzathine penicillin G (BPG) prophylaxis in Rheumatic Heart Disease in Children, Latent Rheumatic Heart Disease and Rheumatic Heart Disease, sponsored by Children's National Research Institute. Status unknown at 1 site in Uganda. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-10-01.
Sponsored by Children's National Research Institute · Phase 2, Interventional, and Treatment
Among 15 studies in Rheumatic Heart Disease with a site in Uganda — 6 open to participants now, 6 under way, 2 of them phase 3. Rheumatic Heart Disease · Uganda.
Among the 15 studies in Rheumatic Heart Disease with a site in Uganda, this one is the 7th largest by enrollment of the 12 interventional ones that give a count, is the only one that started in 2018, is one of 2 in phase 2, and was the 3rd registered.
61 studies on the registry are indexed under Rheumatic Heart Disease; 25 are open to participants now.
Browse Rheumatic Heart Disease studies →6 of the 15 studies in Rheumatic Heart Disease with a site in Uganda are open now. Recruiting first, the newest first:
Children's Hospital Medical Center, Cincinnati · Sites in Uganda
Ages 5–20
Children's Hospital Medical Center, Cincinnati · Sites in Uganda
Ages 5+
Children's Hospital Medical Center, Cincinnati · Sites in Uganda
Ages 5–8 · Healthy volunteers
Children's Hospital Medical Center, Cincinnati · Sites in Uganda
Ages 5–8
Children's Hospital Medical Center, Cincinnati · Sites in Uganda
Healthy volunteers
A study can be open while its sites in Uganda have not opened yet or have stopped. Only those recruiting at a site in Uganda →
Of the 11 Rheumatic Heart Disease studies recruiting now, 5 (45%) set no upper age limit and 5 (45%) stop at 75 or younger; 8 take children under 18; 4 take healthy volunteers.
This study: 5 Years to 17 Years · all sexes · no healthy volunteers.
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15 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 807 is above the median of 221 across 37 interventional studies indexed under Rheumatic Heart Disease.
Median enrollment 865 across the 12 interventional studies, 1,423 across the 3 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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None of the 15 has an industry lead sponsor. The 4 most frequent:
Children's National Research Institute is the lead sponsor of 127 studies on the registry; 47 are open to participants now.
Children's National Research Institute has 1 study filed under Rheumatic Heart Disease — fewer than ten, so there is no comparison to draw.
1 of the studies in Rheumatic Heart Disease with a site in Uganda that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05783375Children's Hospital Medical Center, CincinnatiAccelerating Delivery of rheUmatic Heart Disease Preventive iNterventions in Northern Uganda | 2027-01-31 |
Among the 15 studies in Rheumatic Heart Disease with a site in Uganda, from their registry updates:
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Rheumatic heart disease (RHD) affects at least 32.9 million people, mostly children living in low-resource settings. Long-term intramuscular benzathine penicillin G (BPG) prophylaxis is proven to prevent progression of chronic valve changes in patients with established rheumatic heart disease (RHD) and to allow regression of valve changes in patients with a history of acute rheumatic fever (ARF) with mild RHD. However, in low-resource settings ARF is an elusive diagnosis, and most patients (85%) are diagnosed only when RHD is severe and irreversible, medications ineffective, and surgical intervention is expensive and/or unavailable.
Identification of latent RHD might be an opportunity to substantially reduce RHD morbidity and mortality. However, detection of latent RHD is only important if outcomes are improved. The appropriate management of children with latent RHD is unknown and no formal recommendations exist. While some clinicians prescribe penicillin prophylaxis for children with latent RHD, clinical equipoise exists regarding the best practice.
To fill this gap, the investigators propose a randomized controlled trial in children with latent RHD to evaluate the efficacy of BPG prophylaxis compared to no prophylaxis. Our primary outcome measure is progression of valvular changes on echocardiogram at 2 years. A sample size of 916 children is needed to detect a 50% reduction of progression (expected range 7.5-12.5% progression in BPG-arm vs. 15%-25% progression in control-arm) with 90% power.
AIM 1: To compare the proportion of children (aged 5-17 years) with latent RHD receiving BPG prophylaxis who progress to worse valvular disease at 2-years compared to children not receiving BPG prophylaxis.
Hypothesis 1: Prophylaxis with BPG will result in fewer children with latent RHD showing progression of echocardiographic valve changes at 2 years compared to children with latent RHD not receiving BPG prophylaxis. (The investigators expect at least a 50% relative reduction in progression in the BPG arm: range 15%-25% control arm vs. 7.5-12.5% BPG-arm.)
AIM 2: To compare the proportion of children (aged 5-17 years) with latent RHD receiving BPG prophylaxis who regress to improved valvular disease at 2-years compared to children not receiving BPG prophylaxis.
Hypothesis 2: Prophylaxis with BPG will result in more children with latent RHD showing regression of echocardiographic valve changes by 2 years compared to children with latent RHD not receiving BPG prophylaxis. (The investigators expect at least a 50% relative increase in regression in the BPG arm: range 10-20% control arm vs. 20-40% BPG arm.)
This study is highly significant because it will establish if BPG prophylaxis improves outcomes for children with latent RHD. Feasibility will be ensured through the experience, resources, community support, and accessible patient population of our investigational team. The results of our study will have high impact, immediately informing international policy on the standard of care for children diagnosed with latent RHD and shaping, over 2-3 years, practical and scalable programs that could substantially decrease the global burden of RHD.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients will be excluded from the study for the following reasons:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intramuscular BPG prophylaxis (600,000 IU for children \<30kg, 1.2 million IU for children ≥30kg), every 28 days
Drug: intramuscular benzathine penicillin G (BPG) prophylaxis
No prophylaxis
Intramuscular BPG prophylaxis (600,000 IU for children \<30kg, 1.2 million IU for children ≥30kg), every 28 days.
Also known as: benzathine penicillin G, BPG, penicillin prophylaxis
progression of valvular changes on echocardiogram at 2 years
To compare the proportion of children (aged 5-17 years) with latent RHD receiving BPG prophylaxis who progress to worse valvular disease at 2-years compared to children not receiving BPG prophylaxis
Time frame: 2 years
regression of vavular changes on electrocardiogram at 2 years
To compare the proportion of children (aged 5-17 years) with latent RHD receiving BPG prophylaxis who regress to improved valvular disease at 2-years compared to children not receiving BPG prophylaxis
Time frame: 2 years
Plan to share: No
Started Jun 2018 (actual). Primary completion is estimated for Nov 2020, 29 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Penicillin G Benzathine
Children's National Research Institute →