A Phase 3, Multicentre, Randomised, Investigator-blinded, Parallel-groupStudy of the Safety and Efficacy of Intravenous Daptomycin (Cubicin®)Compared With That of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects With cSSSI
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 265
- 试验地点
- 1
- 主要终点
- Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)
研究概览
简要总结
The objectives of this study is to evaluate the Safety and Efficacy of Intravenous Daptomycin (Cubicin®)Compared with that of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects with Complicated Bacterial Skin and Skin Structure Infection due to Gram-Positive Pathogens.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of inform consent
- •A diagnosis of of complicated skin and skin structure infection known or suspected to be due to Gram-positive bacteria
- •Diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor, including infections involving deeper soft tissue or requiring surgical intervention, a pre-existing lesion or underlying condition affect healing
排除标准
- •Subjects known to have any bloodstream infection (including bloodstream infection caused by S. aureus). Subjects whose baseline blood cultures are positive for any clinically pathogenic organism ( including S. aureus ) should be discontinued from study
- •Minor or superficial skin infections, Infected "decubitus"ulcer, Perirectal abscess, Hidradenitis suppurativa, Myositis, Multiple infected ulcers at distant sites, Infected burn wounds of a large area,
- •Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (eg, amputation)
- •Conditions requiring emergent surgical intervention at the site of infection (eg, progressive necrotizing infections)
研究组 & 干预措施
AZ drug
Daptomycin
干预措施: Daptomycin (Drug)
Comparator
Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin
干预措施: Vancomycin (Drug)
结局指标
主要结局
Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)
时间窗: baseline to TOC(test of cure), for up to 4 weeks
Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood
Change in Creatinine Clearance
时间窗: baseline to TOC(test of cure), for up to 4 weeks
Change in Serum Total Creatine Phosphokinase (CPK)
时间窗: baseline to TOC(test of cure), for up to 4 weeks
Change in Urine pH
时间窗: baseline to TOC(test of cure), for up to 4 weeks
Shift in ECG
时间窗: baseline to TOC(test of cure), for up to 4 weeks
percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline
次要结局
- Microbiological Response at TOC(Test of Cure)(baseline and TOC, for up to 4 weeks)
- Microbiological Response at EOT(End of Therapy)(baseline and EOT, for up to 2 weeks)
- Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)(baseline and TOC, for up to 4 weeks)
- Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC(baseline and TOC(test of cure), for up to 4 weeks)
- Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)(baseline and TOC, for up to 4 weeks)
- Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)(baseline and EOT(end of therapy), for up to 2 weeks)
- Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC(baseline and TOC(test of cure), for up to 4 weeks)