A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 667
- 试验地点
- 84
- 主要终点
- Early Clinical Response Rate
研究概览
简要总结
This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults.
Approximately 75 to 100 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment
详细描述
The primary objective is to determine the noninferiority in the early clinical response rate of 6 day oral TR-701 FA compared with that of 10-day oral linezolid treatment at the 48-72 Hour Visit in the ITT analysis set in patients with ABSSSI.
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 with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
- •Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections
排除标准
- •Uncomplicated skin infections
- •Severe sepsis or septic shock
- •ABSSSI solely due to gram-negative pathogens
研究组 & 干预措施
TR-701 FA
TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo
干预措施: TR-701 FA (Drug)
Linezolid
Linezolid 600 mg tablets oral twice a day for 10 days
干预措施: Linezolid (Drug)
结局指标
主要结局
Early Clinical Response Rate
时间窗: 48-72 hours
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
次要结局
- Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit(Post-Treatment Evaluation (7-14 days after the End of Therapy))
- Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets(EOT Day 11)
- Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.(Day 11)
- Investigator's Assessment of Clinical Response at the 48-72 Hour Visit(48-72 Hour Visit)
- Change From Baseline in Patient-reported Pain, by Study Visit(Multiple)
- To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set(Post-Treatment Evaluation (7-14 days after the End of Therapy))
- Investigator's Assessment of Clinical Response at the Day 7 Visit(Day 7)