RecruitingNot ApplicableNCT06325293

A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study

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

Sponsor

Christoph Berger

Enrollment

376 participants

Start Date

Jan 28, 2025

Study Type

INTERVENTIONAL

Conditions

Community Acquired Pneumonia in Children Mycoplasma Pneumoniae Mycoplasma Pneumoniae Pneumonia

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

Min Age: 3 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Azithromycin Pfizer® and a drug called Placebo for people with community acquired pneumonia in children, mycoplasma pneumoniae, and other related conditions. The study is currently recruiting participants at 13 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzithromycin Pfizer®

Azithromycin 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

DRUGPlacebo

Control comparator arm: 5 days of placebo

Locations(13)

Children's Hospital Aarau, Switzerland

Aarau, Canton of Aargau, Switzerland

University of Basel Children's Hospital, Switzerland

Basel, Canton of Basel-City, Switzerland

University Children's Hospital Bern, Switzerland

Bern, Canton of Bern, Switzerland

Department of Pediatrics, Fribourg Hospital, Switzerland

Fribourg, Canton of Fribourg, Switzerland

Children's Hospital of Geneva, University Hospitals of Geneva, Switzerland

Geneva, Canton of Geneva, Switzerland

Children's Hospital of Central Switzerland, Switzerland

Lucerne, Canton of Lucerne, Switzerland

Children's Hospital of Eastern Switzerland St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Department of Pediatrics, Department Mother-Woman-Child, Lausanne University Hospital, Switzerland

Lausanne, Canton of Vaud, Switzerland

Department of Pediatrics, Cantonal Hospital Winterthur, Switzerland

Winterthur, Canton of Zurich, Switzerland

University Children's Hospital Zurich, Switzerland

Zurich, Canton of Zurich, Switzerland

Department of Pediatrics, Triemli Hospital Zurich, Switzerland

Zurich, Canton of Zurich, Switzerland

Institute of Pediatrics of Southern Switzerland, EOC, Bellinzona, Switzerland

Bellinzona, Canton Ticino, Switzerland

Department of Pediatrics, Cantonal Hospital Graubuenden, Switzerland

Chur, Kanton Graubünden, Switzerland

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NCT06325293

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