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.
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.
Diagnosis defined as the treating physician's documented diagnosis of CAP; AND
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
Tachypnea (defined as respiratory rate (RR) above age-specific reference value) during the assessment in ED (triage or clinical examination).
Contraindication to azithromycin: Documented allergy to azithromycin; cardiovascular disease, including bradycardia, arrhythmias, and/or QT-interval prolongation*; myasthenia gravis.
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.
Christoph Berger
Lead sponsor
University Children's Hospital, Zurich
Sponsor institution
Swiss National Science Foundation
Collaborator
Swiss Clinical Trial Organisation
Collaborator
SwissPedNet
Collaborator