A Randomized Controlled Non-inferiority Trial of Placebo Versus Macrolide Antibiotics for Mycoplasma Pneumoniae Infection in Children With Community-acquired Pneumonia - the MYTHIC Study
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 17
Healthy Volunteers: f
View:
• 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:
‣ 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).
• 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.
Locations
Other Locations
Switzerland
Children's Hospital Aarau, Switzerland
ACTIVE_NOT_RECRUITING
Aarau
University of Basel Children's Hospital, Switzerland
RECRUITING
Basel
Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland
NOT_YET_RECRUITING
Bellinzona
University Children's Hospital Bern, Switzerland
RECRUITING
Bern
Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland
RECRUITING
Chur
Department of Pediatrics, Fribourg Hospital, Switzerland
NOT_YET_RECRUITING
Fribourg
Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland
NOT_YET_RECRUITING
Geneva
Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland
NOT_YET_RECRUITING
Lausanne
Children's Hospital of Central Switzerland, Switzerland
RECRUITING
Lucerne
Children's Hospital of Eastern Switzerland St. Gallen
RECRUITING
Sankt Gallen
Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland
RECRUITING
Winterthur
Department of Pediatrics, Triemli Hospital Zurich, Switzerland
NOT_YET_RECRUITING
Zurich
University Children's Hospital Zurich, Switzerland
RECRUITING
Zurich
Contact Information
Primary
Patrick M Meyer Sauteur, PD Dr. Dr. med.
patrick.meyersauteur@kispi.uzh.ch
0041 44 266 78 96
Backup
Margarete Von Wantoch, Dr. rer. nat.
Margarete.VonWantoch@kispi.uzh.ch
0041 044 266 38 32
Time Frame
Start Date:2025-01-28
Estimated Completion Date:2028-12-31
Participants
Target number of participants:376
Treatments
Active_comparator: IMP arm
Azithromycin Pfizer® powder for oral suspension:~1 daily dose for 5 days, 10mg/kg/day on day 1 and 5mg/kg/day on days 2-5