Doxycycline vs. Macrolide for MRMP (DOMINO)

NCT07306234 · tracked via the Priya Life Science South Korea tracker

Sponsor

Young June Choe

Phase

Phase 4

Started

2026-03-01

Last updated

2025-12-29

Condition(s) studied

Mycoplasma PneumoniaeMycoplasma Pneumoniae Pneumonia

Investigational drug(s) / intervention(s)

Doxycycline →Azithromycin →

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.

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.

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.

Eligibility

Sex

ALL

Min age

3 Years

Max age

17 Years

Healthy volunteers

Inclusion Criteria: * Age: 3 to 17 years at the time of enrollment. * Diagnosis: Clinically diagnosed CAP characterized by respiratory symptoms (e.g., fever, cough, auscultatory findings) and chest X-ray confirming pulmonary infiltrates. * Pathogen: Confirmed MP M. pneumoniae infection via PCR OR strongly suspected infection based on clinical features and epidemiological grounds (e.g., outbreaks among classmates, poor response to prior non-macrolide antibiotics). * Resistance: Suspected macrolide-resistant M. pneumoniae (MRMP) infection (e.g., during a reported local epidemic of MRMP). * Timing: Ability to register and initiate the study drug within 72 hours of symptom onset. Exclusion Criteria: * Prior use of tetracyclines, macrolides, or quinolones for the current illness. * Complicated pneumonia (e.g., necrosis, empyema, lung abscess) or severe pneumonia requiring immediate intensive care or exhibiting hypoxia (SpO₂ \<90%). * Hypersensitivity or contraindications to macrolides or tetracyclines. * Severe immunocompromised state or severe underlying lung disease. * Severe hepatic impairment (AST/ALT \>3x upper limits) or severe renal impairment.

Primary outcome measure(s)

Defervescence rate — 72 hours
Defervescence rate at 72 hours. Defervescence is defined as the maintenance of body temperature below 38.0°C for at least 24 consecutive hours without antipyretics.

Trial sites (14)

Facility	City	Region
Department of Pediatrics, Pusan National University School of Medicine, Pusan National University Children's Hospital, Yangsan, Republic of Korea	Busan	South Korea
Department of Pediatrics, Gyeongsang National University College of Medicine, Gyeongsang National University Changwon Hospital, Changwon, Republic of Korea	Changwon	South Korea
Department of Pediatrics, Chosun University College of Medicine, Chosun University Hospital, Gwangju, Republic of Korea	Gwangju	South Korea
Department of Pediatrics, Jeju National University School of Medicine, Jeju National University Hospital, Jeju, Republic of Korea	Jeju City	South Korea
Department of Pediatrics, CHA University School of Medicine, CHA Bundang Medical Center, Seongnam, Republic of Korea	Seongnam	South Korea
Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea	Seongnam	South Korea
Department of Pediatrics, College of Medicine, The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, Republic of Korea	Seoul	South Korea
Department of Pediatrics, College of Medicine, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Republic of Korea	Seoul	South Korea
Department of Pediatrics, Eulji University School of Medicine, Eulji University Hospital, Seoul, Republic of Korea	Seoul	South Korea
Department of Pediatrics, Korea University College of Medicine, Korea University Anam Hospital, Seoul, Republic of Korea	Seoul	South Korea
Department of Pediatrics, Korea University College of Medicine, Korea University Guro Hospital, Seoul, Republic of Korea	Seoul	South Korea
Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Children's Hospital, Seoul, Republic of Korea	Seoul	South Korea
Department of Pediatrics, Seoul National University College of Medicine, Seoul National University Children's Hospital, Seoul, Republic of Korea	Seoul	South Korea
Department of Pediatrics, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea	Seoul	South Korea

On this site

📄 Zithromax (azithromycin) drug profile →

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07306234 on ClinicalTrials.gov ↗ ← All trials in South Korea