A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 698
- 试验地点
- 2
- 主要终点
- Clinical Cure Rate at Test of Cure (TOC) (MITT Population)
研究概览
简要总结
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
详细描述
Additional purpose of the study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.
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
- •Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.
排除标准
- •Prior treatment of current cSSSI with an antimicrobial.
- •Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.
研究组 & 干预措施
Ceftaroline for Injection
干预措施: Ceftaroline (Drug)
IV Vancomycin and IV Aztreonam
干预措施: IV Vancomycin plus IV Aztreonam (Drug)
结局指标
主要结局
Clinical Cure Rate at Test of Cure (TOC) (MITT Population)
时间窗: 8-15 days after the end of treatment
Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary. Failure: Requirement of alternative antimicrobial therapy for primary infection of cSSSI due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI. Indeterminate: Inability to determine an outcome
Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population
时间窗: 8-15 days after last dose of study drug
次要结局
- Microbiological Success Rate at the TOC Visit(8-15 days after last dose of study drug)
- Clinical Relapse at the Late Follow Up (LFU) Visit(21 to 35 days after the last dose of study drug)
- Microbiological Reinfection or Recurrence at the LFU Visit(21 to 35 days after the last dose of study drug)
- Assess Safety(First dose of study drug through TOC visit)
- Clinical and Microbiological Response by Pathogen at the TOC Visit(8-15 days after last dose of study drug)
- Clinical Response at the End of Therapy (EOT) Visit(Last day of study drug administration)