A Phase 2, Multicenter, Randomized, Open-label, Comparative Study to Evaluate the Efficacy and Safety of Intramuscular Ceftaroline Versus Intravenous Linezolid in Adult Subjects With Complicated Skin and Skin Structure Infections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (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 and skin structure infections in adults.
详细描述
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. The primary focus is bacterial infection.
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
- None
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
- •Complicated skin and skin structure infection (cSSSI)
- •Require initial hospitalization, or treatment in an emergency room or urgent care setting
排除标准
- •Hypersensitivity or allergic reaction to any ß-lactam, ceftaroline, linezolid, aztreonam, or to their components
- •Concomitant use of adrenergic or serotonergic agent
- •Uncomplicated skin and skin structure infection
- •Concomitant therapy with any drug known to exhibit a contraindicated drug-drug interaction
- •More than 24 hours of treatment with an antimicrobial within 96 hours before randomization
- •Known or suspected endocarditis, osteomyelitis, or septic arthritis
- •Severely impaired renal function
- •Evidence of significant hepatic, hematologic, or immunologic disease
研究组 & 干预措施
Ceftaroline
Intramuscular every 12 hours
干预措施: ceftaroline (Drug)
linezolid plus optional aztreonam
Intravenous every 12 hours
干预措施: linezolid (Drug)
linezolid plus optional aztreonam
Intravenous every 12 hours
干预措施: Aztreonam (Drug)
结局指标
主要结局
Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population
时间窗: Test of Cure Visit (8 to 15 days after end of therapy)
The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.
Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population
时间窗: Test of Cure Visit (8 to 15 Days after end of therapy)
The coprimary efficacy outcome measures were the per-subject clinical cure rate at the TOC Visit in the CE and MITT Populations. Subjects were considered clinically cured at the TOC Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.
次要结局
- Clinical Cure Rate at the TOC Visit in the cMITT Population(TOC Visit (8 to 15 days after end of therapy))
- Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations.(End-of-therapy (EOT) visit)
- The Microbiological Response at the TOC Visit in the mMITT and ME Populations.(TOC Visit (8 to 15 days after end of therapy))
- Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations(TOC Visit (8 to 15 days after end of therapy))
- Clinical Relapse at the Late Follow-up Visit(Late Follow-up (LFU) Visit (21 to 35 days after end of therapy))
- The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit(LFU Visit (21 to 35 days after end of therapy))
- The Safety of Ceftaroline Fosamil(First dose of study drug through LFU Visit or 30 days after the last dose of study drug)