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Doxycycline vs. Macrolide for MRMP (DOMINO)
Sponsor: Young June Choe
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.
Official title: Efficacy and Safety of Doxycycline Versus Macrolides for Mycoplasma Pneumoniae Infection in Children (DOMINO): A Protocol for a Multicenter, Randomized, Open-Label, Superiority Trial
Key Details
Gender
All
Age Range
3 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
208
Start Date
2026-03-01
Completion Date
2029-02-28
Last Updated
2025-12-29
Healthy Volunteers
No
Interventions
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.
Locations (14)
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