A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 726
- 主要终点
- Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population
研究概览
简要总结
This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3 study of tedizolid phosphate (TR-701 FA) 200 mg intravenous (IV) once daily for 7 days versus linezolid (Zyvox®, Zyvoxid®, etc) 600 mg IV every 12 hours for 10 days for the treatment of ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP), collectively referred to as ventilated nosocomial pneumonia (VNP). Participants with concurrent gram-positive bacteremia are to receive 14 days of active therapy in either treatment arm.
The primary objective is to determine the noninferiority (NI) in all-cause mortality (ACM) within 28 days after randomization of IV tedizolid phosphate compared with IV linezolid in the Intent to Treat (ITT) Analysis Set (NI is declared when the lower bound of the 95% CI > -10).
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
- •Requires IV antibiotic therapy with diagnosis of ventilated nosocomial pneumonia
- •Gram-positive bacteria on respiratory Gram stain
排除标准
- •Pneumonia of community, viral, fungal or parasitic etiology
- •Structural lung abnormalities
- •Immunosuppression
- •Previous antibiotics for > 24 hours
- •Expected survival of < 72 hours
研究组 & 干预措施
Tedizolid phosphate IV
Ventilated HABP/VABP participants receive tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.
干预措施: Tedizolid phosphate (Drug)
Linezolid IV
Ventilated HABP/VABP participants receive linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.
干预措施: Linezolid (Drug)
结局指标
主要结局
Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population
时间窗: Up to 28 days
The numbers of participants with all-cause mortality within 28 days after randomization was determined in the ITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.
次要结局
- Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population(1-3 days after completing study therapy (Days 8-10 or Days 15-17))
- Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (mITT) Population(7-14 days after end of therapy - TOC)
- Number of Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population(Up to 28 days)
- Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population(7-14 days after end of therapy - TOC)
- Number of Methicillin-Susceptible Staphylococcus Aureus (MSSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population(Up to 28 days)
- Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiologically-Evaluable 1 (ME-1) Population(1-3 days after completing study therapy (Days 8-10 or Days 15-17))
- Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiologically-Evaluable 2 (ME-2) Population(7-14 days after end of therapy - TOC)
- Number of Participants With ≥1 Adverse Events (AEs)(Up to 32 days)
- Number of Participants Discontinuing Study Therapy Due to an Adverse Event (AE)(Up to 14 days)
- Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population(7-14 days after end of therapy - TOC)
- Number of Methicillin-Resistant Staphylococcus Aureus (MRSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population(Up to 28 days)