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NCT Number: NCT07798232

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

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.

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Key information

Conditions

Rheumatic Heart Disease in Children Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Gram-Positive Bacterial Infections Heart Diseases Infections Rheumatic Fever Rheumatic Heart Disease Streptococcal Infections

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Oral Penicillin V

Drug

Twice-daily oral Pen V 250 mg

Primary outcomes

  1. Cumulative Incidence of Rheumatic Heart Disease

    Time frame: 3 years

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

Secondary outcomes

  1. Cumulative Incidence of RHD at One Year

    Time frame: 1 year

    Proportion of participants with newly diagnosed rheumatic heart disease based on blinded echocardiographic adjudication.

  2. Number of Participants who Develop Acute Rheumatic Fever

    Time frame: 3 years

    Percentage of participants who develop acute rheumatic fever (ARF) diagnosed according to the 2015 Revised Jones Criteria among participants in each study arm.

  3. Cumulative Incidence of RHD at Two Years

    Time frame: 2 years

    Proportion of participants with newly diagnosed rheumatic heart disease based on blinded echocardiographic adjudication.

  4. Number of Participants who Develop Early RHD

    Time frame: 3 years

    Proportion of participants who develop Stage A or Stage B rheumatic heart disease as determined by blinded echocardiographic adjudication.

  5. Number of Participants who Develop Advanced RHD

    Time frame: 3 years

    Proportion of participants who develop Stage C or Stage D rheumatic heart disease as determined by blinded echocardiographic adjudication.

  6. Number of Participants Experiencing Treatment-Emergent Adverse Events

    Time frame: 3 years

    Number and proportion of participants experiencing treatment-emergent adverse events, serious adverse events, treatment discontinuations, or other safety-related events attributable to oral Penicillin V.

  7. Number of Participants Achieving at least 80% Adherence to Oral Penicillin V Prophylaxis Based on Pill Count

    Time frame: 3 years

    Proportion of participants assigned to Arm 2 who achieve ≥80% adherence to prescribed oral Penicillin V prophylaxis, as assessed by pill count. At each bimonthly school-based visit, remaining tablets will be counted and adherence calculated as the proportion of prescribed doses taken during the assessment interval.

  8. Number of Participants Achieving at Least 80% Adherence to Oral Penicillin V Prophylaxis Based on DoseSmart® Bottle Opening Records

    Time frame: 3 years

    Proportion of participants assigned to Arm 2 who achieve ≥80% adherence to prescribed oral Penicillin V prophylaxis, as assessed using DoseSmart® electronic bottle opening data downloaded at each bi-monthly visit. Adherence will be calculated as the proportion of expected dosing events recorded over the assessment interval.

  9. Number of Participants Achieving at Least 80% Adherence to Oral Penicillin V Prophylaxis Based on Caregiver-Reported Dosing Diary

    Time frame: 3 years

    Proportion of participants assigned to Arm 2 who achieve ≥80% adherence to prescribed oral Penicillin V prophylaxis, as assessed using a participant/parent paper diary in which caregivers record each administered dose. Adherence will be calculated as the proportion of prescribed doses documented as taken during the assessment interval.

Study contacts

Contact information is provided by the study sponsor or research team.

Alison Spaziani

CONTACT

[email protected]

703-347-3271

Mary Banks

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Murdoch Childrens Research Institute
  • Ochsner Health System
  • The University of Western Australia
  • Uganda Heart Institute

Registry information

Acronym: MEERCATS 2

Important dates

Study start
2027
Primary completion
2031
Study completion
2032
First posted
Sep 1, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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