A Phase 2 Multi-Center, Randomized, Double-Blind, Non-Controlled Study Comparing the Safety, Tolerance, and Efficacy of TR-701 in Patients With Complicated Skin and Skin Structure Infections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 12
- 主要终点
- Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set
研究概览
简要总结
The purpose of the study is to determine the oral dosage of TR-701 to be used in Phase III studies in patients with 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with complicated skin and skin structure infection with at least 2 signs and symptoms
- •Suspected or confirmed infection due to a gram-positive organism
排除标准
- •Complicated skin and skin structure infection due to gram-negative organisms
- •Complicated skin and skin structure infections requiring more than 7 days of therapy
- •Uncontrolled diabetes
- •Chronic systemic immunosuppressive therapy
- •AIDS with CD4 count < 200 cells/mm3
- •Uncontrolled hypertension
- •Mild moderate or severe renal failure
- •Severe hepatic disease
- •Neutropenia
- •Use of antidepressants such as SSRIs or MAOIs for 14 days before first dose of study drug
- •Women who are pregnant or nursing
研究组 & 干预措施
TR-701 200 mg
干预措施: TR-701 200 mg (Drug)
TR-701 300 mg
干预措施: TR-701 300 mg (Drug)
TR-701 400 mg
干预措施: TR-701 400 mg (Drug)
结局指标
主要结局
Clinical Response Rate at Test of Cure in the Clinically Evaluable Analysis Set
时间窗: 7 to 14 days after the last dose of study drug
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
Clinical Response Rate at Test of Cure in the Clinical Modified Intent to Treat Analysis Set
时间窗: 7-14 days after last dose of study drug
Clinical response was defined as resolution or improvement of signs and symptoms of the complicated skin and skin structure infection so that no further antibiotic therapy was required.
次要结局
- Microbiological Response Rate at Test of Cure in the Microbiologically Evaluable Analysis Set(7-14 days after last dose of study drug)
- Microbiological Recurrence at Late Follow-up in Clinical Modified Intent to Treat Analysis Set(21-28 days after last study drug)
- Population PK(Multiple)
- Response Rate at End of Therapy(last day of study treatment)
- Clinical Outcome at the Late Follow-up Visit in the Clinical Modified Intent to Treat Analysis Set(21 to 28 days after the last study drug)
- To Evaluate the Safety Profile of Tedizolid Phosphate(Multiple)