A Phase 3, Randomized, Double Blind, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections 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
- 862
- 试验地点
- 1
- 主要终点
- Clinical Response
研究概览
简要总结
Study 0017 compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.
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
- •Patients must have a diagnosis of one of the following complicated skin and skin structure infections with Methicillin Resistant Staphylococcus aureus (MRSA) either suspected or confirmed as the major cause of the infection:
- •major abscess requiring surgical incision and drainage
- •infected burn (see exclusion criteria for important qualifications)
- •deep/extensive cellulitis
- •infected ulcer (see exclusion criteria for important qualifications)
- •wound infections
- •Patients must be expected to require at least 7 days of intravenous antibiotic treatment
排除标准
- •Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy prior to randomization
- •Burns involving > 20% of body surface area or third-degree/full-thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fascitis, gas gangrene, or mediastinitis.
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
The Clinical Response for each patient was determined by the investigator by assessing a patient's clinical signs and symptoms at the specified evaluation compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.
次要结局
未报告次要终点