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A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study

RecruitingNAAges 3 Years - 17 YearsAllChristoph Berger
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In plain words

What the trial is, and whether it could suit you

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: Is antibiotic treatment needed in Mycoplasma pneumoniae (a specific bacterium) induced pneumonia? Participants will receive either a placebo or a antibiotic treatment and track their symptoms and vital signs until they are healthy. Researchers will then compare the length of symptoms between the placebo and the antibiotic group.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion criteria for screening phase: * 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. * Clinical diagnosis of CAP: 1. Diagnosis defined as the treating physician's documented diagnosis of CAP; AND 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 3. Tachypnea (defined as respiratory rate (RR) above age-specific reference value) during the assessment in ED (triage or clinical examination). * Written screening consent for participation in screening phase signed by parents/legal guardians and the patient if ≥14 years of age. Additional inclusion criteria for intervention phase: * Positive Mp screening test result with the Mp IgM lateral flow assay (LFA) (grade 2 or 3). * Written informed consent for participation in intervention phase signed by parents or legal guardians and the patient if ≥14 years of age. Exclusion criteria: Exclusion criteria for screening phase: • None. Exclusion criteria for intervention phase: * Contraindication to azithromycin: Documented allergy to azithromycin; cardiovascular disease, including bradycardia, arrhythmias, and/or QT-interval prolongation\*; myasthenia gravis. \*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/or trial management team (TMT). * Underlying comorbidities: Cystic fibrosis or other chronic lung disorders (excluding asthma), primary or secondary immunodeficiency, sickle-cell anemia, or severe cerebral palsy. * 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. * Antibiotic treatment against Mp within the previous 7 days, including macrolides, tetracyclines, or fluoroquinolones. * Referral to ICU directly from the ED. * Inability to take oral medication. * 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).
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What it tests

  • Azithromycin Pfizer®
  • Placebo
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Where

13 sites
Children's Hospital Aarau, Switzerland
Aarau, Switzerland
University of Basel Children's Hospital, Switzerland
Basel, Switzerland
University Children's Hospital Bern, Switzerland
Bern, Switzerland
Department of Pediatrics, Fribourg Hospital, Switzerland
Fribourg, Switzerland
Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland
Geneva, Switzerland
Children's Hospital of Central Switzerland, Switzerland
Lucerne, Switzerland
Children's Hospital of Eastern Switzerland St. Gallen
Sankt Gallen, Switzerland
Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland
Lausanne, Switzerland

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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