NCT00442832已完成2 期
A Phase 2, Randomized, Double Blind, Study of Intravenous TD 1792 Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Clinical response
研究概览
简要总结
The purpose of this study is to determine whether TD-1792 is safe and effective when used to treat complicated skin and skin structure infections caused by Gram-positive bacteria.
详细描述
TD-1792 is compared to vancomycin for the treatment of cSSSI.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •major abscess requiring surgical incision and drainage,infected burn, deep/extensive cellulitis, infected ulcer, wound infections
- •requires at least 7 days of intravenous antibiotic treatment
排除标准
- •more than 24 hours of antibiotic therapy
- •moderate or severe liver disease
- •severely neutropenic
- •baseline QTc > 500 msec, congenital long QT syndrome, uncompensated heart failure, uncorrected abnormal K+ or Mg++ blood levels or severe left ventricular hypertrophy
研究组 & 干预措施
TD-1792
Experimental
干预措施: TD-1792 (Drug)
Vancomycin
Active Comparator
干预措施: Vancomycin (Drug)
结局指标
主要结局
Clinical response
时间窗: 7 to 14 days after last antibiotic dose
次要结局
未报告次要终点
研究者
研究点 (1)
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