A Randomized, Double-blind, Multicenter Study to Establish the Safety and Efficacy of Ceftobiprole Medocaril Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 679
- 试验地点
- 32
- 主要终点
- Early Clinical Response
研究概览
简要总结
This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and skin structure infections (ABSSSIs).
详细描述
This was a randomized, double-blind, active-controlled, parallel-group, multicenter study in adult hospitalized patients with ABSSSIs. Randomization was stratified by study site and type of ABSSSI (with major cutaneous abscess comprising ≤ 30% of the Intent-to-Treat [ITT] population).
Primary endpoint for FDA: Early clinical response based on the percent reduction in lesion size at 48-72 hours compared to baseline in patients who did not receive rescue therapy and were alive, in the ITT population.
Primary endpoint for EMA: Investigator-assessed clinical success at the test-of-cure (TOC) visit 15-22 days after randomization, in the co-primary ITT and Clinically Evaluable (CE) populations.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ceftobiprole medocaril
Patients treated with ceftobiprole medocaril 500 mg q8h (with dose adjustment for renal impairment).
干预措施: ceftobiprole medocaril (Drug)
vancomycin+aztreonam
Patients treated with vancomycin 1000 mg (or 15 mg/kg) q12h plus aztreonam 1000 mg q12h (both with dose adjustment for renal impairment).
干预措施: vancomycin+aztreonam (Drug)
结局指标
主要结局
Early Clinical Response
时间窗: 48-72 hours after start of study drug treatment
Comparison of early clinical response, including ≥ 20% reduction from baseline in the primary lesion area (based on ruler measurements), survival for ≥ 72 hours and no rescue therapy in the ITT population
次要结局
- Investigator-assessed Clinical Success in the Clinically Evaluable (CE) Population(15-22 days after randomization)
- Investigator-assessed Clinical Success in the ITT Population(15-22 days after randomization)