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

NCT06325293 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Community Acquired Pneumonia in Children
  • Mycoplasma Pneumoniae
  • Mycoplasma Pneumoniae Pneumonia

Interventions

DRUG

Azithromycin 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

DRUG

Placebo

Control comparator arm: 5 days of placebo

Sponsors & Collaborators

  • Swiss National Science Foundation

    collaborator OTHER

  • Swiss Clinical Trial Organisation

    collaborator UNKNOWN

  • SwissPedNet

    collaborator UNKNOWN

  • Christoph Berger

    lead OTHER

Principal Investigators

  • Christoph Berger, Prof. Dr. med. · University Children's Hospital, Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-28
Primary Completion
2028-11-30
Completion
2028-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06325293 on ClinicalTrials.gov