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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Community Acquired Pneumonia in Children, Mycoplasma Pneumoniae, Mycoplasma Pneumoniae Pneumonia

In brief

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.

Key facts

Study ID

NCT06325293

Run by

Christoph Berger

People needed

376

Starts

2025-01-28

Expected to finish

2028-12-31

Last updated by the study team

2026-05-05

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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).

Where it is running

• Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland — Chur, Kanton Graubünden, Switzerland (enrolling)
• University of Basel Children's Hospital, Switzerland — Basel, Canton of Basel-City, Switzerland (enrolling)
• University Children's Hospital Bern, Switzerland — Bern, Canton of Bern, Switzerland (enrolling)
• Children's Hospital of Central Switzerland, Switzerland — Lucerne, Canton of Lucerne, Switzerland (enrolling)
• Children's Hospital of Eastern Switzerland St. Gallen — Sankt Gallen, Canton of St. Gallen, Switzerland (enrolling)
• Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland — Winterthur, Canton of Zurich, Switzerland (enrolling)
• University Children's Hospital Zurich, Switzerland — Zurich, Canton of Zurich, Switzerland (enrolling)
• Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland — Lausanne, Canton of Vaud, Switzerland
• Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland — Bellinzona, Canton Ticino, 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 Aarau, Switzerland — Aarau, Canton of Aargau, Switzerland
• Department of Pediatrics, Triemli Hospital Zurich, Switzerland — Zurich, Canton of Zurich, Switzerland

Full record on ClinicalTrials.gov

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