Doxycycline vs. Macrolide for MRMP (DOMINO)

Официальное название

Efficacy and Safety of Doxycycline Versus Macrolides for Mycoplasma Pneumoniae Infection in Children (DOMINO): A Protocol for a Multicenter, Randomized, Open-Label, Superiority Trial

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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. Consis

Первичные конечные точки

• Defervescence rate [Срок оценки: 72 hours]

Вторичные конечные точки (7)

• Hospitalization Rate [Срок оценки: Up to 30 days]
• Length of Hospital Stay [Срок оценки: Up to 30 days]
• Hospital Readmission Rate [Срок оценки: Up to 30 days]
• Treatment Failure Rate at Day 7 [Срок оценки: 7 days]
• Time to Resolution of Respiratory Symptoms [Срок оценки: Up to 30 days]
• Time to Radiological Resolution of Infiltrates [Срок оценки: Up to 30 days]
• Incidence of Tooth Discoloration in Children Under 8 Years [Срок оценки: Day 28]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 14 центров

• Department of Pediatrics, Pusan National University School of Medicine, Pusan National Uni — Busan
• Department of Pediatrics, Gyeongsang National University College of Medicine, Gyeongsang N — Changwon
• Department of Pediatrics, Chosun University College of Medicine, Chosun University Hospita — Gwangju
• Department of Pediatrics, Jeju National University School of Medicine, Jeju National Unive — Jeju City
• Department of Pediatrics, CHA University School of Medicine, CHA Bundang Medical Center, S — Seongnam
• Department of Pediatrics, Seoul National University College of Medicine, Seoul National Un — Seongnam
• Department of Pediatrics, College of Medicine, The Catholic University of Korea, Eunpyeong — Seoul
• Department of Pediatrics, College of Medicine, The Catholic University of Korea, Seoul St. — Seoul
• … и ещё 6 центров

Публикации

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• Jiao R, Xue B, Zhang M. A Multiform Optimization Framework for Constrained Multiobjective Optimization. IEEE Trans Cybern. 2023 Aug;53(8):5165-5177. doi: 10.1109/TCYB.2022.3178132. Epub 2023 Jul 18. PMID 35687640

Идентификаторы

NCT: NCT07306234 · DOMINO · KNIH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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