A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia With a Focus on Patients With Infections Due to Methicillin-Resistant Staphylococcus Aureus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 771
- 试验地点
- 1
- 主要终点
- Clinical Response
研究概览
简要总结
Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration.
排除标准
- •Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization.
研究组 & 干预措施
Telavancin
干预措施: Telavancin (Drug)
Vancomycin
干预措施: Vancomycin (Drug)
结局指标
主要结局
Clinical Response
时间窗: 7-14 days following end of antibiotic treatment
Clinical Response: Categorical (Cured, Failed or Indeterminate) * Failure - at least one of the following: * Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy * Termination of study med due to "lack of efficacy" * Death on or after Day 3 attributable to primary infection * Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress. * Indeterminate: Inability to determine outcome
次要结局
未报告次要终点