[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Christoph Berger\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":53},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100541087","a-trial-of-placebo-versus-macrolide-for-mycoplasma-pneumoniae-childhood-pneumonia-mythic-study-100541087",false,"NCT06325293","A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study","A Randomized Controlled Non-inferiority Trial of Placebo Versus Macrolide Antibiotics for Mycoplasma Pneumoniae Infection in Children With Community-acquired Pneumonia - the MYTHIC Study","MYTHIC","Inclusion criteria for screening phase:\n\n* Children aged 3-17 years (from 3rd up to 18th birthday) presenting to the emergency department (ED) who will be managed ambulatory or will be admitted to general ward.\n* Clinical diagnosis of CAP:\n\n  1. Diagnosis defined as the treating physician's documented diagnosis of CAP; AND\n  2. Fever ≥38.0°C (measured by any method \\[i.e., ear, axillary, rectal, or forehead site\\] in the ED or via parent report observed in the last 24h); AND\n  3. Tachypnea (defined as respiratory rate (RR) above age-specific reference value) during the assessment in ED (triage or clinical examination).\n* Written screening consent for participation in screening phase signed by parents\u002Flegal guardians and the patient if ≥14 years of age.\n\nAdditional inclusion criteria for intervention phase:\n\n* Positive Mp screening test result with the Mp IgM lateral flow assay (LFA) (grade 2 or 3).\n* Written informed consent for participation in intervention phase signed by parents or legal guardians and the patient if ≥14 years of age.\n\nExclusion criteria:\n\nExclusion criteria for screening phase:\n\n• None.\n\nExclusion criteria for intervention phase:\n\n* Contraindication to azithromycin: Documented allergy to azithromycin; cardiovascular disease, including bradycardia, arrhythmias, and\u002For QT-interval prolongation\\*; myasthenia gravis.\n\n  \\*Co-medication with arrhythmogenic or QT-interval-prolonging drug (www.qtdrugs.org) is no exclusion criteria but will be discussed with the local investigators and\u002For trial management team (TMT).\n* Underlying comorbidities: Cystic fibrosis or other chronic lung disorders (excluding asthma), primary or secondary immunodeficiency, sickle-cell anemia, or severe cerebral palsy.\n* History of recurrent pneumonia (two or more episodes) or severe pneumonia (ICU admission or complications of CAP such as lung abscess, effusion, and empyema) in lifetime.\n* Antibiotic treatment against Mp within the previous 7 days, including macrolides, tetracyclines, or fluoroquinolones.\n* Referral to ICU directly from the ED.\n* Inability to take oral medication.\n* Parents are unlikely to reliably complete follow up (FUP) visits and questionnaires (e.g., due to language barriers or living far from the study site).","ALL","3 Years","17 Years",{"count":21,"type":22},376,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to compare a placebo (a look-alike substance that contains no active drug) with a commonly used antibiotic in children with Mycoplasma pneumoniae (a specific bacterium) induced community-acquired pneumonia. The main question it aims to answer is:\n\nIs antibiotic treatment needed in Mycoplasma pneumoniae (a specific bacterium) induced pneumonia?\n\nParticipants will receive either a placebo or a antibiotic treatment and track their symptoms and vital signs until they are healthy.\n\nResearchers will then compare the length of symptoms between the placebo and the antibiotic group.",[28,29,30],"Community Acquired Pneumonia in Children","Mycoplasma Pneumoniae","Mycoplasma Pneumoniae Pneumonia",[32,33,34,35,36,37,38,39],"Mycoplasma pneumoniae","community-acquired pneumonia","randomized controlled trial","Investigator Initiated Clinical Trial (IICT)","Paediatric pneumonia","children","placebo","macrolides","RECRUITING","2026-04-29",{"date":43,"type":44},"2026-05-05","ACTUAL",{"date":46,"type":44},"2025-01-28",{"date":48,"type":22},"2028-12-31",{"name":50,"class":51},"Christoph Berger","OTHER",13,""]