A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil Compared to Linezolid Administered Intravenously and Orally to Adult Subjects With Acute Bacterial Skin and Skin Structure Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 7
- 主要终点
- Early Clinical Response at the Early Assessment Visit (ITT Population)
研究概览
简要总结
The purpose of this study is to determine whether contezolid acefosamil 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
contezolid acefosamil
contezolid acefosamil 1500 mg IV x 1 dose, followed by 1000 mg IV q12h for at least 3 total IV doses, followed by 1300 mg PO q12h for 10 to 14 days
干预措施: contezolid acefosamil (Drug)
linezolid
linezolid 600 mg IV q12h for at least 3 total IV doses, followed by 600 mg PO q12h for 10 to 14 days
干预措施: linezolid 600 mg (Drug)
结局指标
主要结局
Early Clinical Response at the Early Assessment Visit (ITT Population)
时间窗: 48 to 72 hours after the start of study drug
Early clinical response assessment based on the electronic case report form (eCRF) data at Early Assessment (48-72 hours after start of study drug) where a successful response (i.e., "responder") was defined as a reduction in primary ABSSSI lesion size ≥20% compared to baseline, and the subject did not receive a non-protocol specified systemic antibacterial agent with activity against Gram-positive organisms for the treatment of ABSSSI and did not die of any cause up to Early Assessment.
次要结局
未报告次要终点