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 …
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.
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Eligibility Criteria
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 document…
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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