NCT07164131招募中4 期
Azithromycin Versus Doxycycline in Hospitalized Adult Patients With Community Acquired Pneumonia Treated With Beta-lactams
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 1,120
- 试验地点
- 10
- 主要终点
- Hospital-free days
研究概览
简要总结
The purpose of this study is to compare effectiveness and safety of Azithromycin versus Doxycycline in adult patients hospitalized with community acquired pneumonia (CAP) treated with Beta-lactams.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients (>18 years old) admitted with CAP and receiving a beta-lactam antibiotic plus a form of atypical coverage (azithromycin or doxycycline) in the ED within 12 hours of admission.
排除标准
- •High clinical suspicion for Legionella pneumonia
- •Allergy or contraindication to the use of either azithromycin or doxycycline (usual clinical practice)
- •Antibiotics not for CAP
- •Pregnant women (based on clinical assessment as part of standard of care)
- •Severe CAP as defined by the ATS/IDSA criteria
- •Corrected QT prolongation (> 440 ms in men and > 460 ms in women)
- •Receiving a different antibiotic (e.g quinolones)
- •Admission > 24 hours
- •Known to be a prisoner
研究组 & 干预措施
Doxycycline group
Active Comparator
Subjects hospitalized for community acquired pneumonia will receive standard of care treatment with Doxycycline
干预措施: Doxycycline (Drug)
Azithromycin group
Active Comparator
Subjects hospitalized for community acquired pneumonia will receive standard of care treatment with Azithromycin
干预措施: Azithromycin (Drug)
结局指标
主要结局
Hospital-free days
时间窗: 28 days
Number of days subject remained out of hospital
次要结局
- Oxygen-free days(28 days)
- 180-day mortality(180 days)
- Need for advanced respiratory support or in-hospital mortality(Up to 28 days)
研究者
Yewande Odeyemi, MD
Principal Investigator
Mayo Clinic
研究点 (10)
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