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A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study
Sponsor: Christoph Berger
Summary
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.
Official title: A Randomized Controlled Non-inferiority Trial of Placebo Versus Macrolide Antibiotics for Mycoplasma Pneumoniae Infection in Children With Community-acquired Pneumonia - the MYTHIC Study
Key Details
Gender
All
Age Range
3 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
376
Start Date
2025-01-28
Completion Date
2028-12-31
Last Updated
2025-03-30
Healthy Volunteers
No
Conditions
Interventions
Azithromycin Pfizer®
Azithromycin Pfizer® powder for oral suspension will be used in the active comparator arm: 1 daily dose for 5 days, 10mg/kg/day on day 1 and 5mg/kg/day on days 2-5
Placebo
Control comparator arm: 5 days of placebo
Locations (13)
Children's Hospital Aarau, Switzerland
Aarau, Canton of Aargau, Switzerland
University of Basel Children's Hospital, Switzerland
Basel, Canton of Basel-City, Switzerland
University Children's Hospital Bern, Switzerland
Bern, Canton of Bern, Switzerland
Department of Pediatrics, Fribourg Hospital, Switzerland
Fribourg, Canton of Fribourg, Switzerland
Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland
Geneva, Canton of Geneva, Switzerland
Children's Hospital of Central Switzerland, Switzerland
Lucerne, Canton of Lucerne, Switzerland
Children's Hospital of Eastern Switzerland St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland
Lausanne, Canton of Vaud, Switzerland
Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland
Winterthur, Canton of Zurich, Switzerland
University Children's Hospital Zurich, Switzerland
Zurich, Canton of Zurich, Switzerland
Department of Pediatrics, Triemli Hospital Zurich, Switzerland
Zurich, Canton of Zurich, Switzerland
Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland
Bellinzona, Canton Ticino, Switzerland
Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland
Chur, Kanton Graubünden, Switzerland