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.
Parallel
Azithromycin Pfizer®
DrugAzithromycin 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
DrugControl comparator arm: 5 days of placebo
Co-primary outcome: days to normalization of all vital signs
Time (days) to normalization of all vital signs for at least 24h (efficacy), defined as temperature \<38.0°C, respiratory rate and heart rate within age-specific reference ranges, and peripheral oxygen saturation (SpO2) on room air ≥93% assessed up to 28 days.
Co-primary outcome: community-acquired pneumonia(CAP)-related change in patient care status
CAP-related change in patient care status within 28 days (safety), such as (re-)admission or ICU transfer assessed up to 28 days.
Overall clinical outcome
Overall clinical outcome based on benefits and harms (DOOR/RADAR approach) according to documentation of clinical response (normalization of all VS) and solicited adverse events (AEs) 1x/24h at the end of treatment (day 5) and each FUP visit.
Time (days) to normalization of CAP-related symptoms
Time (days) to normalization of CAP-related symptoms assessed up to 28 days.
Quality of Life (QoL) Assessment assessing impact of the child's pneumonia on the family's social and health-related well-being
QoL assessment of the patient's family with the pediatric quality of life inventory TM (PedsQLTM) family impact module and generic core scales questionnaire until day 28.
Time (days) to return to daily routine
Time (days) to return to daily routine, defined as return to childcare/school/work of patients and their families.
Length of hospital stay (LOS)
LOS (days) in hospitalized patients after index hospitalization.
Number of unscheduled medical visits
Number of unscheduled medical visits (apart from the study) until day 28.
Proportion of patients (re-)treated with antibiotics for any reason
Proportion of patients (re-)treated with antibiotics for any reason until 28 days and total antibiotic exposure in days up to 28 days.
Side effects/AEs/serious AE (SAE)s of investigational medicinal product (IMP)
Side effects/AEs/SAEs of IMP.
Click on the lead sponsor to view all of their trials.
Christoph Berger
Lead sponsor
University Children's Hospital, Zurich
Sponsor institution
Swiss National Science Foundation
Collaborator
Swiss Clinical Trial Organisation
Collaborator
SwissPedNet
Collaborator
