A Randomized, Evaluator-Blinded, Phase 3 Study to Compare the Safety and Efficacy of PTK 0796 With Linezolid in the Treatment of Adults With Complicated Skin and Skin Structure Infection
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Clinical success at follow-up
研究概览
简要总结
A Phase III 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-0805 the safety and efficacy of PTK 0796 in the treatment of cSSSI will be compared to an antibiotic approved for this indication by the 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
- 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
- •Has and acute complicated skin and skin structure infection with findings of systemic inflammatory response
- •Patients, ages 18 years or older
- •Is expected to require greater than or equal to 4 days antibiotic therapy
- •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 the past 1 month
- •Has been previously enrolled in this protocol
- •Has received >48hr of potentially effective systemic antibiotic immediately prior to study drug
- •Is nursing
研究组 & 干预措施
PTK 0796
PTK 0796 100mg for injection; PTK 0796 tablet 150mg
干预措施: PTK 0796 (Drug)
Linezolid
For gram positive treatment: Linezolid 600 mg tablets and pre-mixed 600mg IV infusion solution; For gram negative treatment: Moxifloxacin 400 mg tablets and pre-mixed 400mg IV infusion solution
干预措施: Linezolid (Drug)
结局指标
主要结局
Clinical success at follow-up
时间窗: 4 weeks after enrollment
次要结局
- To evaluate safety of dosing regimens(4 weeks after enrollment)