NCT02269319已完成2 期
A Phase 2, Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of MRX-I Versus Linezolid in Adult Subjects With Acute Bacterial Skin and Skin Structure Infection
MicuRx0 个研究点目标入组 120 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline
研究概览
简要总结
The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial 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
- Double (Participant, Investigator)
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
- •Prior systemic antibiotics within 96 hours of randomization
研究组 & 干预措施
MRX-I
Experimental
MRX-I tablets 800 mg given twice a day for 10 days
干预措施: MRX-I (Drug)
Linezolid
Active Comparator
Linezolid 600 mg given twice a day for 10 days
干预措施: Linezolid (Drug)
结局指标
主要结局
Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline
时间窗: 48-72 hours
* Did not receive a systemic antibacterial agent with activity against gram-positive organisms * Did not die of any cause up to EA
次要结局
- Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline(Day 10)
研究者
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