Shortened Antibiotic Treatment in Community-Acquired Pneumonia: A Nationwide Danish Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 395
- 试验地点
- 14
- 主要终点
- 90-day survival
研究概览
简要总结
CAP5 is an investigator-initiated multicentre non-inferiority randomized controlled trial which aims to assess the efficacy and safety of shortened antibiotic treatment duration of community-acquired pneumonia (CAP) in hospitalized adult patients based on clinical stability criteria.
Five days after initiation of antimicrobial therapy for CAP, participants are randomized 1:1 to parallel treatment arms: 5 days (intervention) or minimum 7 days (control) of antibiotic treatment. The intervention group discontinues antibiotics at day 5 if clinically stable and afebrile for at least 48 hours. The control group receives antibiotics for a duration of 7 days or longer at the discretion of the treating physician.
The primary outcome is 90-day readmission-free survival which will be tested with a non-inferiority margin of 6%.
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
- Single (Outcomes Assessor)
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
- •Hospitalized with community-acquired pneumonia; defined as new pulmonary infiltrate on chest X-ray and at least one symptom compatible with pneumonia (cough, fever, dyspnoea and/or chest pain)
- •Initiation of antibiotics within 12 hours of the time of the chest X-ray with an infiltrate
- •Age ≥ 18 years
- •Afebrile (temperature ≤ 37.8 °C) for 48 hours at randomization
- •Clinically stable at randomization (systolic blood pressure ≥ 90 mm Hg, heart rate ≤ 100/min., respiratory rate ≤ 24/min., peripheral oxygen saturation ≥ 90%)
排除标准
- •Immunosuppression (HIV-positive, neutropenia, corticosteroid treatment (≥10 mg/day of prednisone or the equivalent for >30 days), chemotherapy, immunosuppressive agents, immunosuppressed after solid organ transplantation, asplenia)
- •Hospitalization during the previous 14 days
- •Antibiotic treatment (>2 days) within the past 30 days
- •Uncommon cause requiring longer duration of antimicrobial therapy (Pseudomonas aeruginosa, Staphylococcus aureus, Mycobacterium spp., fungi)
- •Extrapulmonary infection (e.g. endocarditis, meningitis, or abscess)
- •Pleural empyema or lung abscess
- •Pleural effusion requiring drainage tube
- •Intensive care unit (ICU) admittance
- •Pregnancy and breastfeeding
结局指标
主要结局
90-day survival
时间窗: within 90 days
次要结局
- Length of hospital stay(within 90 days)
- Use of antimicrobials after discharge(within 90 days)
- Serious adverse events(within 90 days)
- Readmissions(days 30 and 90)
- Antibiotic adverse events(within 90 days)
- Post-discharge follow-up visits(within 90 days)
- Mortality(in-hospital, days 30 and 90)
- Duration of antibiotic treatment(within 90 days)
- Major complications(within 90 days)
研究者
Thomas Benfield
Clinical Professor
Hvidovre University Hospital