NCT02241941撤回4 期
Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters of daptomycin
研究概览
简要总结
The purpose of this study is to determine single dose pharmacokinetics of daptomycin consecutively in 10 patients on three different time points after severe burn injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Male or female of 18 years or older
- •Second and/or third degree thermal injury
- •Total body surface area burned ≥ 15%
- •Hospitalisation in the ICU for burn injured patients of the University Hospital Zürich
- •Probability of ICU stay of >14 days
- •Written informed consent by the patient or in patients unable to be informed or to sign according to section 4.4 of the study protocol
排除标准
- •Evidence of renal failure (Creatinine clearance <30ml/min) or continuous renal replacement therapy such as continuous hemofiltration
- •History of muscle disease or skeletal muscle disorder
- •Creatine-phosphokinase (CPK) ≥ 5 times the upper limit of normal (ULN)
- •History of hypersensitivity to the drug
- •Pregnancy
- •Severe coagulation disorder
研究组 & 干预措施
Daptomycin
Experimental
干预措施: Daptomycin (Drug)
结局指标
主要结局
Pharmacokinetic parameters of daptomycin
时间窗: up to 30 days
次要结局
- Correlation of daptomycin plasma concentrations with tissue concentration(up to 30 days)
- degree of variability of daptomycin pk parameters in dependency of body surface area burned(up to 30 days)
研究者
研究点 (1)
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