Comparing a placebo to an antibiotic for pneumonia in children

A Randomized Controlled Non-inferiority Trial of Placebo Versus Macrolide Antibiotics for Mycoplasma Pneumoniae Infection in Children With Community-acquired Pneumonia - the MYTHIC Study

This study is testing if an antibiotic called azithromycin helps children aged 3-17 with pneumonia caused by Mycoplasma pneumoniae get better faster than a placebo.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 376 (estimated)
• Ages: 3 Years to 17 Years
• Sex: All
• Sponsor: University Children's Hospital, Zurich (other)
• Locations: 13 sites (Aarau, Canton of Aargau and 12 other locations)
• Trial ID: NCT06325293 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of macrolide antibiotics compared to a placebo in treating community-acquired pneumonia caused by Mycoplasma pneumoniae in children aged 3-17 years. Participants will be randomly assigned to receive either the antibiotic azithromycin or a placebo for five days, and their symptoms and vital signs will be monitored until recovery. The study seeks to determine whether antibiotic treatment is necessary for this specific type of pneumonia, addressing concerns about antibiotic resistance and the appropriate use of antibiotics in pediatric care.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 3-17 years with a clinical diagnosis of community-acquired pneumonia and a confirmed Mycoplasma pneumoniae infection.

Not a fit: Patients who do not have Mycoplasma pneumoniae infection or those with severe underlying health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help clarify the necessity of antibiotic treatment for Mycoplasma pneumoniae pneumonia, potentially reducing unnecessary antibiotic use in children.

How similar studies have performed: Previous studies have indicated the need for further investigation into the treatment of Mycoplasma pneumoniae pneumonia, making this approach both relevant and necessary.

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 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).

Where this trial is running

Aarau, Canton of Aargau and 12 other locations

• Children's Hospital Aarau, Switzerland — Aarau, Canton of Aargau, Switzerland (ACTIVE_NOT_RECRUITING)
• University of Basel Children's Hospital, Switzerland — Basel, Canton of Basel-City, Switzerland (RECRUITING)
• University Children's Hospital Bern, Switzerland — Bern, Canton of Bern, Switzerland (RECRUITING)
• Department of Pediatrics, Fribourg Hospital, Switzerland — Fribourg, Canton of Fribourg, Switzerland (NOT_YET_RECRUITING)
• Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland — Geneva, Canton of Geneva, Switzerland (NOT_YET_RECRUITING)
• Children's Hospital of Central Switzerland, Switzerland — Lucerne, Canton of Lucerne, Switzerland (RECRUITING)
• Children's Hospital of Eastern Switzerland St. Gallen — Sankt Gallen, Canton of St. Gallen, Switzerland (RECRUITING)
• Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland — Lausanne, Canton of Vaud, Switzerland (NOT_YET_RECRUITING)
• Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland — Winterthur, Canton of Zurich, Switzerland (RECRUITING)
• University Children's Hospital Zurich, Switzerland — Zurich, Canton of Zurich, Switzerland (RECRUITING)
• Department of Pediatrics, Triemli Hospital Zurich, Switzerland — Zurich, Canton of Zurich, Switzerland (NOT_YET_RECRUITING)
• Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland — Bellinzona, Canton Ticino, Switzerland (NOT_YET_RECRUITING)
• Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland — Chur, Kanton Graubünden, Switzerland (RECRUITING)

Study contacts

• Study coordinator: Patrick M Meyer Sauteur, PD Dr. Dr. med.

Conditions: Community Acquired Pneumonia in Children, Mycoplasma Pneumoniae, Mycoplasma Pneumoniae Pneumonia, Mycoplasma pneumoniae, community-acquired pneumonia, randomized controlled trial, Investigator Initiated Clinical Trial, Paediatric pneumonia