A Randomized Controlled Non-inferiority Trial of Placebo Versus Macrolide Antibiotics for Mycoplasma Pneumoniae Infection in Children With Community-acquired Pneumonia - the MYTHIC Study
Led by Christoph Berger · Updated on 2026-05-05
376
Participants Needed
13
Research Sites
4 weeks
Total Duration
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AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
Research Publications
Sponsors
C
Christoph Berger
Lead Sponsor
S
Swiss National Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether antibiotic treatment is necessary for children with community-acquired pneumonia caused by the bacterium Mycoplasma pneumoniae. This trial compares the effects of a commonly used antibiotic, azithromycin, with a placebo in children aged 3 to 17 years. The study addresses concerns about increasing antibiotic resistance and aims to improve treatment decisions for this common cause of pneumonia in children.
Participants are randomly assigned to receive either azithromycin or a placebo for five days. The azithromycin group takes a daily dose of 10mg/kg on the first day followed by 5mg/kg on days 2 through 5. This randomized, double-blind, placebo-controlled trial takes place across multiple pediatric centers and includes both ambulatory and hospitalized children. The study involves initial screening to confirm Mycoplasma pneumoniae infection using a specific antibody test before starting the assigned treatment.
During the study, researchers will monitor symptom duration, vital signs, and changes in patient care status for up to 28 days. They will also assess overall clinical outcomes, symptom resolution, quality of life impacts on the family, time to return to normal daily activities, and the development of any complications related to the infection. Follow-up includes clinical examinations and parent reports to track progress and safety throughout the study period.
CONDITIONS
Brief Title
A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study
Who Can Participate
Age: 3Years - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
Children aged 3 to 17 years (from 3rd up to 18th birthday) presenting to emergency department for ambulatory or general ward care
Clinical diagnosis of community-acquired pneumonia defined by physician
Fever of 38.0°C or higher observed in last 24 hours
Tachypnea above age-specific reference during emergency assessment
Positive Mycoplasma pneumoniae IgM lateral flow assay (grade 2 or 3) for intervention phase
Written consent signed by parents or guardians and patient if 14 years or older
You will not qualify if you...
Allergy to azithromycin or cardiovascular conditions including bradycardia, arrhythmias, or QT-interval prolongation
Myasthenia gravis
Chronic lung disorders other than asthma, immunodeficiency, sickle-cell anemia, or severe cerebral palsy
History of recurrent pneumonia (2 or more episodes) or severe pneumonia requiring ICU or complications
Antibiotic treatment against Mycoplasma pneumoniae in previous 7 days
Direct ICU referral from emergency department
Inability to take oral medication
Parents unlikely to complete follow-up visits and questionnaires due to language or distance issues
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 5 days
Participants receive either a 5-day course of azithromycin or placebo to treat Mycoplasma pneumoniae infection causing community-acquired pneumonia.
1 baseline visit and daily medication for 5 days
Follow-up
Duration - Up to 28 days after treatment
Participants are monitored for up to 28 days after treatment to assess recovery, symptom normalization, and quality of life impact.
Periodic follow-up assessments during 28 days
Trial Site Locations
Total: 13 locations
1
Children's Hospital Aarau, Switzerland
Aarau, Canton of Aargau, Switzerland, 5001
Active, Not Recruiting
2
University of Basel Children's Hospital, Switzerland
Basel, Canton of Basel-City, Switzerland, 4056
Actively Recruiting
3
University Children's Hospital Bern, Switzerland
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
4
Department of Pediatrics, Fribourg Hospital, Switzerland
Fribourg, Canton of Fribourg, Switzerland, 1708
Not Yet Recruiting
5
Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland
Geneva, Canton of Geneva, Switzerland, 1205
Not Yet Recruiting
6
Children's Hospital of Central Switzerland, Switzerland
Lucerne, Canton of Lucerne, Switzerland, 6000
Actively Recruiting
7
Children's Hospital of Eastern Switzerland St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9006
Actively Recruiting
8
Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland
Lausanne, Canton of Vaud, Switzerland, 1011
Not Yet Recruiting
9
Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland
Winterthur, Canton of Zurich, Switzerland, 8401
Actively Recruiting
10
University Children's Hospital Zurich, Switzerland
Zurich, Canton of Zurich, Switzerland, 8032
Actively Recruiting
11
Department of Pediatrics, Triemli Hospital Zurich, Switzerland
Zurich, Canton of Zurich, Switzerland, 8063
Not Yet Recruiting
12
Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland
Bellinzona, Canton Ticino, Switzerland, 6500
Not Yet Recruiting
13
Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland
Mycoplasma pneumoniae: delayed re-emergence after COVID-19 pandemic restrictions.
Patrick M Meyer Sauteur, Michael L Beeton, European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Mycoplasma and Chlamydia Infections (ESGMAC), and the ESGMAC Mycoplasma pneumoniae Surveillance (MAPS) study group
A randomized controlled non-inferiority trial of placebo versus macrolide antibiotics for Mycoplasma pneumoniae infection in children with community-acquired pneumonia: trial protocol for the MYTHIC Study.
Patrick M Meyer Sauteur, Michelle Seiler, Romy Tilen...