Table 1 Eligibility criteria. CAP community-acquired pneumonia, ED emergency department, FUP follow-up, ICU intensive care unit, Ig immunoglobulin, LFA lateral flow assay
Study phase | Inclusion criteria (all must be fulfilled) | Exclusion criteria (excluded if any of the following are present) |
|---|---|---|
Screening phase | • Children aged 3–17 years (from 3rd up to 18th birthday) presenting to the ED who will be managed ambulatory or will be admitted to general ward. • Clinical diagnosis of CAPa: (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 (respiratory rate above the age-specific reference value as defined in table 5 during the assessment in ED [triage or clinical examination]). • Written informed consent for participation in screening phase signed by parents or legal guardians and the patient if ≥14 years of age. | • None |
Intervention phase | • Positive screening test result with the M. pneumoniae-specific IgM LFA (grade 2 or 3) (Additional file 3: figure). • Written informed consent for participation in intervention phase signed by parents or legal guardians and the patient if ≥14 years of age. | • Contraindication to azithromycin: documented allergy to azithromycin; cardiovascular disease, including bradycardia, arrhythmias, and/or QT-interval prolongationb; 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 M. pneumoniae within the previous 7 days, including macrolides, tetracyclines, or fluoroquinolones. • Referral to ICU directly from the ED (e.g., development of respiratory failure). • Inability to tolerate oral medication. • Parents are unlikely to reliably complete FUP visits and questionnaires (e.g., due to language barriers or living far from the study site). |