Actively Recruiting

Phase Not Applicable
Age: 3Years - 17Years
All Genders
ID06325293

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

On this page

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

Eligible

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
Not Eligible

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

Chur, Kanton Graubünden, Switzerland, 7000

Actively Recruiting

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Research Team

P

Patrick M Meyer Sauteur, PD Dr. Dr. med.

M

Margarete Von Wantoch, Dr. rer. nat.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Improved Diagnostics Help to Identify Clinical Features and Biomarkers That Predict Mycoplasma pneumoniae Community-acquired Pneumonia in Children.

Patrick M Meyer Sauteur, Selina Krautter, Lilliam Ambroggio...

https://pubmed.ncbi.nlm.nih.gov/31665253

Circulating Antibody-Secreting Cell Response During Mycoplasma pneumoniae Childhood Pneumonia.

Patrick M Meyer Sauteur, Johannes Trück, Annemarie M C van Rossum...

https://pubmed.ncbi.nlm.nih.gov/32034406

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

https://pubmed.ncbi.nlm.nih.gov/38008103

Effectiveness of β-Lactam Monotherapy vs Macrolide Combination Therapy for Children Hospitalized With Pneumonia.

Derek J Williams, Kathryn M Edwards, Wesley H Self...

https://pubmed.ncbi.nlm.nih.gov/29084336

Antibiotics for community-acquired lower respiratory tract infections secondary to Mycoplasma pneumoniae in children.

Samantha J Gardiner, John B Gavranich, Anne B Chang

https://pubmed.ncbi.nlm.nih.gov/25566754

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...

https://pubmed.ncbi.nlm.nih.gov/39363201