A Phase 2, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Standard Therapy for Treatment of Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
研究概览
简要总结
Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.
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 either a suspected or confirmed Gram positive organism 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 4 days of intravenous antibiotic treatment
排除标准
- •Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for > 24 hours within 7 days prior to the first dose of study medication unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days).
- •Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.
研究组 & 干预措施
Telavancin
干预措施: Telavancin (Drug)
Standard of care for cSSSI
cSSSI - complicated skin and skin structure infections
干预措施: Vancomycin or antistaphylococcal penicillin (Drug)
结局指标
主要结局
Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
时间窗: 7-14 days following end of antibiotic treatment
* Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary. * Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to the Test-of-Cure (TOC) visit. * Indeterminate: Inability to determine outcome.
次要结局
未报告次要终点