A Randomized, Evaluator-Blinded, Phase 2 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid (Zyvox®) in the Treatment of Adults With Complicated Skin and Skin Structure Infection (cSSSI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population
研究概览
简要总结
A Phase II trial to demonstrate the safety and efficacy of PTK 0796 in the treatment of complicated skin and skin structure infections (cSSSI).
详细描述
The pharmacologic profile of PTK 0796 in humans suggests that it has the potential to be used safely and effectively for this indication. Data from in vitro and animal studies support this hypothesis.
In PTK 0796-CSSI-0702 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by FDA. Initial treatment will be administered intravenously with the option for subsequent oral treatment.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, ages 18 years to 80 years
- •Has an acute complicated skin and skin structure infection
- •Female patients must not be pregnant at the time of enrollment and must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
排除标准
- •Has received an investigational drug within past 1 month
- •Has been previously enrolled in this protocol
- •Has received >48 hr of a potentially effective systemic antibiotic immediately prior to study drug
研究组 & 干预措施
PTK 0796
干预措施: PTK 0796 (Drug)
Linezolid
干预措施: Linezolid (Drug)
结局指标
主要结局
Number of Participants With Clinical Response in the Modified Intent-to-Treat (mITT) Population
时间窗: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Clinical response is defined as clinical success (CS), which is categorized as a determination by a blinded evaluator (BE) that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant (par.) received ≥1 dose of test article, the par. did not receive non-study antibiotics on \>2 calendar days from Day 1 to the Test of Cure assessment, and the par. did not meet any of the criteria for clinical failure. Clinical failure (CF) is categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the par. received potentially effective antibiotics for treatment of the primary infection site on \>2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.
Number of Participants With Clinical Response in the Clinically Evaluable (CE) Population
时间窗: 10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days)
Clinical response is defined as CS, which was categorized as a determination by a BE that the infection had sufficiently resolved such that antibiotics were no longer needed, the participant received ≥1 dose of test article, the participant did not receive non-study antibiotics on \>2 calendar days from Day 1 to the Test of Cure assessment, and the participant did not meet any of the criteria for clinical failure. CF was categorized as a determination by a BE that the infection had responded inadequately such that alternative antibiotics were needed, the BE discontinued test article due to an adverse event that was possibly/probably related to test article, the primary site of infection was surgically removed, or the participant received potentially effective antibiotics for treatment of the primary infection site on \>2 days after study enrollment. A classification of indeterminate is used for any outcome that was not classified as CS or CF.
次要结局
- Number of Participants With Microbiologic Response in the mITT Population(10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days))
- Number of Participants With Microbiologic Response in the Microbiologically Evaluable (ME) Population(10 to 17 days after the last dose of test article (intravenous or oral) (total treatment of up to 14 days))