A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of IV to Oral 6-Day TR-701 Free Acid and IV to Oral 10-Day Linezolid for the Treatment of ABSSSI
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 666
- 试验地点
- 111
- 主要终点
- The Early Clinical Response Rate
研究概览
简要总结
This is a randomized, double-blind, double-dummy, multicenter, global Phase 3 study of IV to oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Patients are to start treatment with at least 2 IV doses and may receive IV therapy for the entire treatment duration.
Approximately 100 to 140 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 (NI) in the early clinical response rate of intravenous (IV) to oral 6 day TR-701 free acid (FA) compared with that of IV to oral 10-day linezolid treatment at 48-72 hours after the first infusion of study drug in the intent-to-treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections (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 requiring IV antibiotic therapy and with systemic signs of infection diagnosed with 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
• TR-701 FA IV followed by TR-701 FA tablets
干预措施: TR-701 FA (Drug)
Linezolid
• Linezolid IV followed by Linezolid Tablets
干预措施: Linezolid (Drug)
结局指标
主要结局
The Early Clinical Response Rate
时间窗: 48-72 hours
Responder: No increase in lesion surface area from baseline.
次要结局
- Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.(Post-Treatment Evaluation (7-14 days after the End of Therapy))
- Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set(End of Therapy Day 11)
- Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit(Post-Treatment Evaluation (7-14 days after the End of Therapy))
- Change From Baseline in Patient-reported Pain, by Study Visit(Multiple)
- Clinical Response at the End of Therapy Visit(Day 11)
- Investigator's Assessment of Clinical Response at the 48-72 Hour Visit(48-72 Hours)
- Investigator's Assessment of Clinical Response at the Day-7 Visit(Day 7)