Penicillin to Prevent Early Rheumatic Heart Disease in School-Aged Children

NCT07798232 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 2026-0638
• Study Type: interventional
• Target: 9,622
• Locations: 1 country
• Sites: 1

Brief Summary

This study will look at whether children ages 5-8 who take Penicillin V by mouth twice a day are less likely to develop rheumatic heart disease (RHD) over a 3-year period compared to children who do not take the medicine.

Conditions

Rheumatic Heart Disease in Children

Keywords

Rheumatic Heart Disease; Pragmatic Randomized Controlled Trial; Oral Penicillin V; Group A Streptococcus

Outcome Measures

Primary Outcomes (1)

• Cumulative Incidence of Rheumatic Heart Disease

  Proportion of participants with newly diagnosed RHD based on blinded echocardiographic adjudication among children with a normal baseline echocardiogram.

  3 years

Secondary Outcomes (9)

• Cumulative Incidence of RHD at One Year

  1 year

• Number of Participants who Develop Acute Rheumatic Fever

  3 years

• Cumulative Incidence of RHD at Two Years

  2 years

• Number of Participants who Develop Early RHD

  3 years

• Number of Participants who Develop Advanced RHD

  3 years

Study Arms (2)

Oral Penicillin V

ACTIVE COMPARATOR

Drug: Oral Penicillin V

No Prophylaxis

NO INTERVENTION

Interventions

Oral Penicillin V DRUG

Twice-daily oral Pen V 250 mg

Oral Penicillin V

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 5-8 years at enrollment
• Residence within the participating study catchment area (Gulu District or Gulu City)
• Normal study echocardiogram confirmed by the expert adjudication panel
• Parent/guardian able and willing to provide written informed consent
• Participant able to provide written assent (age 8 years)

You may not qualify if:

• History of prior ARF or RHD with or without cardiac involvement
• Evidence of RHD on baseline echocardiography
• Congenital heart disease (excluding small PFO, small ASD) or other cardiac abnormality at baseline echocardiography
• Self-reported known allergy to penicillin
• Medical conditions that would preclude safe participation, adherence, or follow-up
• Anticipated inability to complete 36 months of study follow-up
• Any known co-morbid condition requiring regular antibiotic prophylaxis

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• The University of Western Australia: collaborator
• Uganda Heart Institute: collaborator
• Ochsner Health System: collaborator
• Murdoch Childrens Research Institute: collaborator

Study Sites (1)

Uganda Heart Institute

Kampala, Uganda, Uganda

Location

MeSH Terms

Conditions

Rheumatic Heart Disease

Interventions

Penicillin V

Condition Hierarchy (Ancestors)

Rheumatic Fever; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joselyn Rwebembera

  Uganda Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Spaziani

CONTACT

703-347-3271; aspaziani@childrensnational.org

Mary Banks

CONTACT

mary.banks@cchmc.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 1, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): July 31, 2031
• Study Completion (Estimated): March 1, 2032
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)