Phase 4 Study of Once-Daily Intramuscular Cefepime Versus Ceftriaxone for In-Home Treatment of Nursing Home-Acquired Pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Total cost of all antibiotics.
研究概览
简要总结
Randomized trial of nursing home residents with pneumonia to assess if intramuscular cefepime is a safe, efficacious, and cost-effective alternative to once daily intramuscular ceftriaxone for the treatment of elderly nursing home residents who develop pneumonia and do not require hospitalization.
详细描述
To compare the efficacy, safety, and pharmacoeconomics of cefepime versus ceftriaxone. Double-blind study of nursing home residents >60 years of age with pneumonia. Patients were randomized to cefepime or ceftriaxone 1 gm q24h to be administered intramuscularly. After three days, responding patients could be switched to oral antibiotics. Main Outcome Measures: clinical success, adverse events, and cost-effectiveness ratios.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residents of a nursing home for >=30 days who were at least 60 years of age and developed pneumonia not amenable to oral antibiotics while not requiring hospitalization, a new infiltrate on chest Xray, estimated Clcr <=60 mL/min, presence of standard clinical criteria, signed informed consent.
排除标准
- •Allergy to cephalosporins, receipt of >24 hours of an antibiotic (unless no improvement was evident), an existing infection due to a pathogen known resistant to either study drug; expected mortality within 48 hours, immunosuppression, hypotension or respiratory distress requiring ventilatory support, prior limited treatment or supportive care only directives, suspected or known Pseudomonas aeruginosa or MRSA infections, primary lung cancer or another malignancy metastatic to the lungs, bronchial obstruction or a history of post-obstructive pneumonia, or patients receiving renal dialysis.
研究组 & 干预措施
1 cefepime
干预措施: cefepime (Drug)
2 ceftriaxone
干预措施: ceftriaxone (Drug)
结局指标
主要结局
Total cost of all antibiotics.
时间窗: 7-14 days
次要结局
- Clinical efficacy, safety, and cost-effectiveness analysis of total healthcare costs.(7-14 days)