A Multicentre, Open Label, Uncontrolled Clinical Trial to Evaluate Efficacy and Safety of Daptomycin for the Treatment of Complicated Skin and Skin-Structure Infections (cSSTI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Novartis
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start
研究概览
简要总结
This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Daptomycin
350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
干预措施: Daptomycin (Drug)
结局指标
主要结局
Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start
时间窗: at Day 7 and 14
Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.
次要结局
- Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous(At day 14)
- Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE(At day 14)
- Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10(At day 4 and 10)
- Efficacy Assessed by Time of Resolution of Infection(At day 14)
- Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria(At day 4, 7, 10 and 14)
- Evaluated Resource Utilization and Calculated Overall Treatment Cost (Including Treatment Period and Follow-up Period)(at day 14 and follow up day i.e. day 30)