[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654362":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":42,"studyPopulation":42,"armGroups":51,"interventions":60,"overallOfficials":65,"centralContacts":70,"locations":79,"responsibleParty":95,"collaborators":97,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":42,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":129,"whyStopped":42,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,21,24,27,30,33,36,39],{"measure":15,"description":16,"timeFrame":17},"Cumulative Incidence of RHD at One Year","Proportion of participants with newly diagnosed rheumatic heart disease based on blinded echocardiographic adjudication.","1 year",{"measure":19,"description":20,"timeFrame":12},"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.",{"measure":22,"description":16,"timeFrame":23},"Cumulative Incidence of RHD at Two Years","2 years",{"measure":25,"description":26,"timeFrame":12},"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.",{"measure":28,"description":29,"timeFrame":12},"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.",{"measure":31,"description":32,"timeFrame":12},"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.",{"measure":34,"description":35,"timeFrame":12},"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.",{"measure":37,"description":38,"timeFrame":12},"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.",{"measure":40,"description":41,"timeFrame":12},"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\u002Fparent 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.",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":48,"maskingDescription":42,"whoMasked":49},"SINGLE",[50],"OUTCOMES_ASSESSOR",[52,57],{"label":53,"type":54,"description":42,"interventionNames":55},"Oral Penicillin V","ACTIVE_COMPARATOR",[56],"Drug: Oral Penicillin V",{"label":58,"type":59,"description":42,"interventionNames":42},"No Prophylaxis","NO_INTERVENTION",[61],{"type":62,"name":53,"description":63,"armGroupLabels":64,"otherNames":42},"DRUG","Twice-daily oral Pen V 250 mg",[53],[66],{"name":67,"affiliation":68,"role":69},"Joselyn Rwebembera","Uganda Heart Institute","PRINCIPAL_INVESTIGATOR",[71,76],{"name":72,"role":73,"phone":74,"phoneExt":42,"email":75},"Alison Spaziani","CONTACT","703-347-3271","aspaziani@childrensnational.org",{"name":77,"role":73,"phone":42,"phoneExt":42,"email":78},"Mary Banks","mary.banks@cchmc.org",[80],{"facility":68,"status":42,"city":81,"state":82,"zip":42,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Kampala","Uganda","UG",{"type":85,"coordinates":86},"Point",[87,88],32.58219,0.31628,{"lat":88,"lon":87},[91,92,94],{"name":67,"role":73,"phone":74,"phoneExt":42,"email":75},{"name":77,"role":73,"phone":93,"phoneExt":42,"email":42},"513-803-3123",{"name":67,"role":69,"phone":42,"phoneExt":42,"email":42},{"type":96,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[98,100,101,103],{"name":99,"class":6},"The University of Western Australia",{"name":68,"class":6},{"name":102,"class":6},"Ochsner Health System",{"name":104,"class":6},"Murdoch Childrens Research Institute","100654362","phase-3-penicillin-to-prevent-early-rheumatic-heart-disease-in-school-aged-children-100654362",false,"NCT07798232","Penicillin to Prevent Early Rheumatic Heart Disease in School-Aged Children","MEERCATS 2","Inclusion Criteria:\n\n* Age 5-8 years at enrollment\n* Residence within the participating study catchment area (Gulu District or Gulu City)\n* Normal study echocardiogram confirmed by the expert adjudication panel\n* Parent\u002Fguardian able and willing to provide written informed consent\n* Participant able to provide written assent (age 8 years)\n\nExclusion Criteria:\n\n* History of prior ARF or RHD with or without cardiac involvement\n* Evidence of RHD on baseline echocardiography\n* Congenital heart disease (excluding small PFO, small ASD) or other cardiac abnormality at baseline echocardiography\n* Self-reported known allergy to penicillin\n* Medical conditions that would preclude safe participation, adherence, or follow-up\n* Anticipated inability to complete 36 months of study follow-up\n* Any known co-morbid condition requiring regular antibiotic prophylaxis",true,"ALL","5 Years","8 Years",{"count":117,"type":118},9622,"ESTIMATED","INTERVENTIONAL",[121],"PHASE3","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.",[124],"Rheumatic Heart Disease in Children",[126,127,53,128],"Rheumatic Heart Disease","Pragmatic Randomized Controlled Trial","Group A Streptococcus","NOT_YET_RECRUITING","2026-09-01",{"date":132,"type":133},"2026-09-03","ACTUAL",{"date":135,"type":118},"2027-02-01",{"date":137,"type":118},"2032-03-01",{"name":5,"class":6},1]