Ceftaroline Fosamil Versus Standard of Care for Community Acquired Bacterial Pneumonia (CABP): Clinical Outcomes Among Hospitalized Adults at a Single United States Hospital
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Achieving clinical stability
研究概览
简要总结
Community-acquired bacterial pneumonia, which is often called CAP, is a bacterial infection in the lungs and is treated with antibiotics. Sometimes people need to be in the hospital to be treated for CAP. Usually, hospitalized persons with CAP are given two antibiotics together. These antibiotics usually include a cephalosporin and a macrolide. The most commonly used cephalosporin at Albany Medical Center Hospital is ceftriaxone. The most commonly used macrolides at Albany Medical Center Hospital are azithromycin and doxycycline.
This research is being done to find out how well a new cephalosporin antibiotic, called ceftaroline, works in combination with a macrolide for the treatment of CAP. Ceftaroline is similar to ceftriaxone. Ceftaroline was recently approved by the FDA to treat pneumonia in hospitalized patients based on two research studies. In one study, ceftaroline was better than ceftriaxone. In the second study, ceftaroline was just as good as ceftriaxone. Ceftaroline was very well tolerated in both clinical studies and it was found to be as safe as ceftriaxone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •age 18 years or older
- •met ATS/ISDA criteria rule of CABP
- •CABP requiring hospitalization and treatment with a IV antimicrobial
- •anticipated hospitalization for > 48 hours
- •received ceftaroline in combination with a macrolide (clarithromycin, or azithromycin) for > 48 hours within the first 24 hours after presentation to the hospital and must have remained on therapy for at least 48 hours after admission
- •Pneumonia Patient Outcomes Research Team (PORT)risk class III or IV
排除标准
- •CABP PORT Risk class I, II, III
- •CABP requiring admission to an ICU
- •CABP suitable for outpatient therapy with an oral microbial agent
- •confirmed or suspected respiratory tract infection attributed to a source other than CABP pathogens
- •noninfectious case of pulmonary infiltrates or pleural empyema
- •infection with a pathogen know to be resistant to ceftaroline or epidemiological/ clinical context suggesting a high likelihood of a resistant pathogen
- •previous therapy with another intravenous beta-lactam for CABP for between 24 and 96 hours prior to randomization
- •receipt of chronic concomitant systemic steroids > 40 mg of prednisone equivalent
- •significant hepatic disease
- •hematologic disease
- •Immunological disease
- •history of a hypersensitivity reaction to beta-lactams
- •pregnant or nursing females
结局指标
主要结局
Achieving clinical stability
时间窗: day 4
definition of clinically stable: temperature ≤37.8°C, heart rate ≤100 beats/min, systolic blood pressure ≥90 mm Hg, respiratory rate ≤24 breaths/min, oxygen saturation ≥90% or pO2 ≥ 60 mm Hg on room air, and normal mental status; none of the following symptoms worsening: cough, dyspnea, chest pain, sputum production; and ≥ 1 of the aforementioned symptoms improving.
次要结局
- Achieving clinical stability(day 5)
- Hospital Readmission(day 30)
- All-cause mortality(day 30)
研究者
Wayne Triner
Professor and Research Director Dept.of Emergency Medicine
Albany Medical College