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Doxycycline vs. Macrolide for MRMP (DOMINO)

NCT07306234 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2025-12-29

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if doxycycline works to treat pneumonia in children. It focuses on children with Mycoplasma pneumoniae infection that may not respond to standard medicines. The main questions it aims to answer are:

* Does doxycycline stop fevers faster than azithromycin?
* Is doxycycline safe for children, specifically regarding tooth color changes?

Researchers will compare doxycycline to azithromycin to see if doxycycline works better to treat this type of pneumonia.

Participants will:

* Take either doxycycline or azithromycin by mouth for 7 to 14 days.
* Check their body temperature to see when their fever goes away.
* Visit the hospital to check for any medical problems.
* Have their teeth checked for color changes 28 days after starting the medicine.

Conditions

  • Mycoplasma Pneumoniae
  • Mycoplasma Pneumoniae Pneumonia

Interventions

DRUG

Doxycycline

Intervention Group (Doxycycline): Participants will receive oral doxycycline (4 mg/kg/day divided into 2 doses for weight ≤45 kg; 100 mg BID for weight \>45 kg). The standard treatment duration is 7 days, which may be extended up to 14 days based on clinical response.

DRUG

Azithromycin

Control Group (Azithromycin): Participants will receive oral azithromycin according to the standard 5-day regimen (10 mg/kg on Day 1, followed by 5 mg/kg on Days 2-5). Rescue Therapy Protocol: To ensure patient safety, a standardized "rescue therapy" protocol is implemented. Participants in the Control group who fail to demonstrate clinical improvement at the 48-72 hour assessment-defined as persistent fever (≥38.0°C) or clinical deterioration-will be immediately switched to doxycycline. Consistent with the intention-to-treat principle, these cases will be classified as treatment failures for the primary efficacy analysis.

Sponsors & Collaborators

  • Korea Society of Pediatric Infectious Diseases

    collaborator UNKNOWN

  • Korea National Institute of Health

    collaborator UNKNOWN

  • Korea Disease Control and Prevention Agency

    collaborator UNKNOWN

  • DT&CRO

    collaborator UNKNOWN

  • Young June Choe

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2029-01-31
Completion
2029-02-28
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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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 NCT07306234 on ClinicalTrials.gov