Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing.
研究概览
简要总结
The purpose is to investigate daptomycin pharmacokinetics in critically ill patients with suspected or verified bacteremia with Gram-positive cocci undergoing combined continuous hemodiafiltration at a filtration rate of 35ml/kg/h and to establish a dose recommendation for continuous hemodiafiltration at a filtrate rate of 35ml/kg/h.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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 C)
- •Life expectancy of less than 5 days
结局指标
主要结局
Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing.
时间窗: PK on days 1, 3, and 5
15 patients are devided in 3 cohorts of 5 patients each. PK data(measured on day 1, 3 and 5) of the first 5 patients receiving daptomycin 6mg/kg/day during 5 consecutive days additionally to standard antibiotic treatment are compared with PK data of daptomycin 6mg/kg/day in healthy volunteers and dose is adapted in the next 5 patients based on these results. The same is done for the last 5 patients.
次要结局
未报告次要终点