Rheumatic Heart Disease in ChildrenPhase 3MEERCATS 2NCT07798232
Penicillin to Prevent Early Rheumatic Heart Disease in School-Aged Children
A Phase 3 study testing Oral Penicillin V in people with Rheumatic Heart Disease in Children, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Heart Disease in Children
- What is being tested?
- Oral Penicillin V
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,622 participants
- Where
- 1 siteUganda
- Study dates
- 1 Feb 2027to 1 Mar 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mary Banks contact
Uganda1 site
Uganda Heart Institute
Kampala, Uganda
Joselyn Rwebembera, 703-347-3271, aspaziani@childrensnational.org
Mary Banks, 513-803-3123
About this study
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
- Being tested
- Oral Penicillin V
- Keywords
- Rheumatic Heart Disease, Pragmatic Randomized Controlled Trial, Oral Penicillin V, Group A Streptococcus
- Medical subject headings
- Rheumatic Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Penicillin VDrug
Twice-daily oral Pen V 250 mg
| Study group | Role | What they receive |
|---|---|---|
| Oral Penicillin V | Active comparator | Not described Receives: Drug: Oral Penicillin V |
| No Prophylaxis | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (9)
Cumulative Incidence of RHD at One Year
Proportion of participants with newly diagnosed rheumatic heart disease based on blinded echocardiographic adjudication.
Measured: 1 year
Number of Participants who Develop Acute Rheumatic Fever
Percentage of participants who develop acute rheumatic fever (ARF) diagnosed according to the 2015 Revised Jones Criteria among participants in each study arm.
Measured: 3 years
Cumulative Incidence of RHD at Two Years
Proportion of participants with newly diagnosed rheumatic heart disease based on blinded echocardiographic adjudication.
Measured: 2 years
Number of Participants who Develop Early RHD
Proportion of participants who develop Stage A or Stage B rheumatic heart disease as determined by blinded echocardiographic adjudication.
Measured: 3 years
Number of Participants who Develop Advanced RHD
Proportion of participants who develop Stage C or Stage D rheumatic heart disease as determined by blinded echocardiographic adjudication.
Measured: 3 years
Number of Participants Experiencing Treatment-Emergent Adverse Events
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.
Measured: 3 years
Number of Participants Achieving at least 80% Adherence to Oral Penicillin V Prophylaxis Based on Pill Count
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.
Measured: 3 years
Number of Participants Achieving at Least 80% Adherence to Oral Penicillin V Prophylaxis Based on DoseSmart® Bottle Opening Records
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.
Measured: 3 years
Number of Participants Achieving at Least 80% Adherence to Oral Penicillin V Prophylaxis Based on Caregiver-Reported Dosing Diary
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Feb 2027 (estimated)
- Primary completion31 Jul 2031 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic Heart Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9,622 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Western Australia, Uganda Heart Institute, Ochsner Health System, Murdoch Childrens Research Institute
- Responsible party
- Sponsor
- Investigators
- Joselyn Rwebembera, Principal investigator, Uganda Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798232
- Sponsor's protocol ID
- 2026-0638
- Acronym
- MEERCATS 2
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penicillin to Prevent Early Rheumatic Heart Disease in School-Aged Children
- ClinicalTrials.gov ID
- NCT07798232
- Acronym / sponsor ID
- MEERCATS 2 / 2026-0638
- Conditions
- Rheumatic Heart Disease in Children
- Keywords
- Rheumatic Heart Disease, Pragmatic Randomized Controlled Trial, Oral Penicillin V, Group A Streptococcus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9,622 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- The University of Western Australia, Uganda Heart Institute, Ochsner Health System, Murdoch Childrens Research Institute
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 31 Jul 2031 (estimated)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Penicillin V | Active comparator | Drug: Oral Penicillin V |
| No Prophylaxis | No intervention | – |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Penicillin VTwice-daily oral Pen V 250 mg | Drug | Oral Penicillin V |
Primary outcome
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.
9 secondary outcomes
Cumulative Incidence of RHD at One Year
Time frame: 1 year
Number of Participants who Develop Acute Rheumatic Fever
Time frame: 3 years
Cumulative Incidence of RHD at Two Years
Time frame: 2 years
Number of Participants who Develop Early RHD
Time frame: 3 years
Number of Participants who Develop Advanced RHD
Time frame: 3 years
Number of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: 3 years
Number of Participants Achieving at least 80% Adherence to Oral Penicillin V Prophylaxis Based on Pill Count
Time frame: 3 years
Number of Participants Achieving at Least 80% Adherence to Oral Penicillin V Prophylaxis Based on DoseSmart® Bottle Opening Records
Time frame: 3 years
Number of Participants Achieving at Least 80% Adherence to Oral Penicillin V Prophylaxis Based on Caregiver-Reported Dosing Diary
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Banks contact
Joselyn Rwebembera principal investigator
Uganda Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral Penicillin V in people with Rheumatic Heart Disease in Children, run by Children's Hospital Medical Center, Cincinnati at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison Spaziani (703-347-3271, aspaziani@childrensnational.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Rheumatic Heart Disease (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.