[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rheumatic-fever\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rheumatic-fever":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100638188","improving-management-and-secondary-prevention-through-azithromycin-comparative-trial-in-rheumatic-heart-disease-in-nigeria--impact-rhd-nigeria-100638188",false,"NCT07625228","Improving Management and Secondary Prevention Through Azithromycin Comparative Trial in Rheumatic Heart Disease in Nigeria)- IMPACT-RHD Nigeria","Oral Azithromycin Versus Intramuscular Penicillin for Secondary Prevention of Rheumatic Heart Disease in Nigerian Secondary School Students: A Comparative Study to Improve Outcomes in Rheumatic Heart Disease Management","IMPACT-RHD","Inclusion Criteria:\n\n* They must be between 10 and 18 years old and have a confirmed diagnosis of mild or moderate RHD.\n* They must be under follow-up care at one of the four trial sites and be capable of attending monthly visits or be picked during routine secondary school screening to be performed as part of the study.\n* At enrollment, patients must demonstrate cognitive capacity to consent (or assent, if a minor) and a willingness to adhere to the study schedule.\n* Females of childbearing potential must agree to avoid pregnancy during the trial.\n* Individuals must not have initiated any alternative RHD prophylaxis regimen before enrollment; the trial will provide all prophylaxis during the study\n\nExclusion Criteria:\n\n* known allergy to penicillin or any history of anaphylaxis to antibiotics.\n* Girls who are pregnant or breastfeeding will be excluded, as well as any patient with severe comorbidities likely to complicate prophylaxis or follow-up. For example, patients with advanced heart failure (NYHA class III-IV), significant chronic kidney or liver disease, uncontrolled diabetes, or other serious chronic illnesses (e.g. active tuberculosis, immunodeficiency).\n* Patients with psychiatric conditions or cognitive impairment that preclude informed consent or reliable adherence will also be excluded.\n* Any patient currently enrolled in another interventional trial, or who is unwilling or unlikely to comply with monthly visits, will be excluded.","ALL","10 Years","18 Years",{"count":21,"type":22},474,"ESTIMATED","INTERVENTIONAL",[25],"NA","Background: Nigeria, among other Low and Middle-income countries, bears one of the highest burdens of RHD in Africa, affecting young to middle-aged adults within their productive years. This leads to loss of productivity, high out-of-pocket costs, and increased mortality risk. Challenges such as such as poverty, overcrowding, limited antibiotic access, and inconsistent prophylaxis contribute to the persistence of the disease. Secondary prophylaxis using intramuscular Benzathine Penicillin G (BPG) serves as the current standard for prevention, but has demonstrated poor adherence due to injection pain, fear, physical, and socioeconomic constraints. Oral Azithromycin offers a potential alternative by overcoming these barriers, providing an effective, acceptable, affordable and sustainable preventive strategy in Nigeria.\n\nMethods and design: A randomised, non-inferiority, open-label, controlled clinical trial conducted across cardiology clinics of four tertiary hospitals in major Nigerian cities, for a duration of 24 months. This study will recruit participants aged 15 to 45 years with mild to moderate RHD cases (stage A or B as defined by World Heart Federation criteria) confirmed by a blinded adjudication panel, comprising 5 expert cardiologists, who will determine the echocardiographic stage of RHD on enrollment and at completion of the study period. Randomisation of participants will be done in a 1:1 ratio to receive either the standard regimen of intramuscular BPG (1.2 million units) every 28 days or a 3-day course of oral Azithromycin (500mg daily) repeated monthly. A total sample size of 474 participants will provide 90% power to demonstrate non-inferiority, using a margin of 4% with allowance for 15% on follow-up losses.\n\nObjectives: The proportion of participants in the oral Azithromycin arm versus the IM BPG arm who demonstrate echocardiographic progression to worsen RHD stages or experience a recurrence of Acute Rheumatic Fever (ARF) within the period of two years will be compared. Additionally, accessing the adherence rates, causes of RHD-related hospitalisations, safety profiles, cost-effectiveness, and patient-reported outcomes, including treatment satisfaction and Health-Related Quality of Life (HRQoL).\n\nSignificance: This trial is designed to highlight the most effective and readily adoptable secondary prevention strategy for Nigeria's young-to-middle-aged population by evaluating patients' adherence, ease of administration, safety profile, drug availability, cost effectiveness, and other practical considerations in resource-limited settings. Establishing a prevention strategy that addresses the socioeconomic, physical barriers of injection-based prophylaxis and improving long-term adherence and clinical outcomes in Nigeria.",[28,29,30],"Rheumatic Fever","Valvular Heart Diseases","Valvular Cardiomyopathy",[32,33,34,35],"secondary prevention","Rheumatic Valvular Heart Disease","Benzathine Penicillin","Azithromycin","NOT_YET_RECRUITING","2026-06-01",{"date":39,"type":40},"2026-06-04","ACTUAL",{"date":42,"type":22},"2027-01-05",{"date":44,"type":22},"2031-12-30",{"name":46,"class":47},"Ladoke Akintola University of Technology, Ogbomoso, Nigeria","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100535990","phase-3-treat-sc-early-short-course-oral-dexamethasone-for-the-treatment-of-sydenham-chorea-in-children-100535990","NCT06259006","TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children","TREAT-SC: A Randomised, Double-Blinded, Placebo-Controlled Trial of Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children","TREAT-SC","Inclusion Criteria:\n\n1. Sydenham's chorea of any severity diagnosed by a paediatrician or neurologist based on national ARF guidelines\n2. Child or adolescents aged 4 years to \\\u003C18 years of age\n\nExclusion Criteria:\n\n1. Administered steroids or intravenous immunoglobulin since onset of the current Sydenham's chorea episode\n2. Evidence of concomitant severe, acute infection\n3. History of hypersensitivity to dexamethasone or its excipients\n4. Pregnancy\n5. Confirmed exposure of an unimmunised child to measles, mumps, rubella or chickenpox within the previous four weeks\n6. Receipt of a live vaccine within the previous four weeks\n7. Medical condition or treatment with medication which in the opinion of the trial investigators would make the child unsuitable for the trial","4 Years","17 Years",{"count":59,"type":22},80,[61],"PHASE3","The purpose of this study is to find out whether an early three-day course of an oral steroid medication (dexamethasone) can improve the physical and mental recovery and wellbeing for children with Sydenham's chorea.\n\nSydenham's chorea is a condition that impacts approximately 12% of children with acute rheumatic fever. It is caused by inflammation in the brain following an abnormal immune response to Group A streptococcus bacterial infection. Sydenham's chorea is a movement disorder that causes children's faces, hands, and feet to move quickly and uncontrollably, and can also affect mood and concentration. The physical recovery from Sydenham's chorea can take two to six months but the mental recovery (e.g. mood and concentration) can take longer to resolve. Sydenham's chorea remains endemic in Māori, Pacific Islander, Aboriginal and Torres Strait Islander children in New Zealand and Australia.\n\nThere is limited evidence to direct treatment of Sydenham's chorea, and clinical practice differs widely around the world. Dexamethasone is an oral steroid which targets the abnormal immune response and successfully treats other immune-mediated brain disorders, with good tolerability.\n\nTREAT-SC is a randomized, double-blinded, placebo-controlled trial which will investigate whether a three day course of oral dexamethasone safely and effectively treats the movement disorder and psychiatric symptoms of Sydenham's chorea. The trial will recruit 80 participants from study sites in Australia and New Zealand.",[28,64],"Sydenham Chorea",[64],"RECRUITING","2025-06-17",{"date":69,"type":40},"2025-06-24",{"date":71,"type":40},"2024-06-17",{"date":73,"type":22},"2028-05",{"name":75,"class":76},"Starship Child Health, Te Toka Tumai Auckland","OTHER_GOV",17]