Efficacy and Safety of Doxycycline Versus Macrolides for Mycoplasma Pneumoniae Infection in Children (DOMINO): A Protocol for a Multicenter, Randomized, Open-Label, Superiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 208
- 试验地点
- 13
- 主要终点
- Defervescence rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Doxycycline (Drug)
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).
干预措施: Azithromycin (Drug)
结局指标
主要结局
Defervescence rate
时间窗: 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.
次要结局
- Hospitalization Rate(Up to 30 days)
- Length of Hospital Stay(Up to 30 days)
- Hospital Readmission Rate(Up to 30 days)
- Treatment Failure Rate at Day 7(7 days)
- Time to Resolution of Respiratory Symptoms(Up to 30 days)
- Time to Radiological Resolution of Infiltrates(Up to 30 days)
- Incidence of Tooth Discoloration in Children Under 8 Years(Day 28)
研究者
Young June Choe
Professor
Korea University Anam Hospital