NCT01219114撤回不适用
A Descriptive Study of the Efficacy and Safety of CUBICIN (Daptomycin) Under Conditions of Actual Use in the Philippines
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- AstraZeneca
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Adverse events observed during the treatment duration
研究概览
简要总结
The purpose of this study is to monitor the safety and efficacy of CUBICIN under conditions of actual use in patients who are diagnosed with complicated Skin and Skin Structure infection (cSSI) or Staphylococcus aureus bacteria including right-sided endocarditis and are prescribed CUBICIN by their physician.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Diagnosis of cSSSI known or suspected to be due to gram-positive bacteria
- •Diagnosis of right-sided endocarditis with one or more positive culture for S. aureus within two days prior to initiation of medication
- •Prescribed daptomycin by patient's attending physician
排除标准
- •Known allergic or serious adverse reaction to daptomycin
- •Patients with pneumonia
- •Patients with baseline CPK values >1000 U/L or 5x ULN
结局指标
主要结局
Adverse events observed during the treatment duration
时间窗: Ranges from during treatment and up to 14 days after last administration of daptomycin (follow up)
Clinical Response determined by cure rate
时间窗: Ranges from during treatment and up to 14 days after last administration of daptomycin
次要结局
未报告次要终点
研究者
研究点 (1)
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