NCT01212432Unknown2 期
Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pharmacokinetics
研究概览
简要总结
Daptomycin kinetics in CRRT
- Trial with medicinal product
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 90 Years（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
- •females: negative pregnancy test
- •Hospitalisation in the medical ICU
- •High suspicion or evidence of Gram-positive infections requiring antibiotic therapy
- •Subjects receiving standard antibiotic treatment for Gram-positive infection
- •Evidence of renal failure
- •Clinical necessity for continuous renal replacement therapy
- •Written informed consent signed by the patient or a next of kin and an independent physician in case the patient is not able to sign.
排除标准
- •Skeletal muscle disorders or CPK levels of > 2 x ULN
- •History of hypersensitivity to the drug
- •Participation in another study
- •Subjects with a history of muscle disease
- •Patients with severe liver function impairment (Child
- •Life expectancy of less than 5 days
结局指标
主要结局
Pharmacokinetics
时间窗: 2011
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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