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
- 5
- 主要终点
- Days alive and out of hospital
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 (> 450 ms in men and > 460 ms in women)
- •Incarcerated individuals (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
Days alive and out of hospital
时间窗: 28 days
Days alive spent outside of the hospital, within 28 days of randomization
Hospital-free days
时间窗: 28 days
Number of days subject remained out of hospital
次要结局
- Need for advanced respiratory support or in-hospital mortality(28 days)
- Need for Advanced Respiratory Support(28 days)
- In-Hospital Mortality(28 days)
- Ordinal clinical status scale(28 days)
- 60-day Mortality(60 days post discharge)
- 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
研究点 (5)
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