临床试验/NCT00925093

NCT00925093撤回1 期

Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

Aarhus University Hospital0 个研究点开始时间: 2011年9月最近更新: 2015年1月26日

适应症

干预措施

试验速览

阶段: 1 期
状态: 撤回
发起方
主要终点: Concentration of antibiotics in cerebrospinal fluid

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Three different antibiotics are used to prevent infection in case of neurosurgery - this study examines to which extent the antibiotics penetrate from the blood to the cerebrospinal fluid (surrounding the brain).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
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: 是

入选标准

•Over 18 years old
•Already having an external CSF drain
•Scheduled for neurosurgery requiring antibiotic prophylaxis (most commonly placement of an internal drain ("shunt")

排除标准

•Infection or colonization requiring other than standard prophylactic antibiotics

研究组 & 干预措施

Vancomycin

Active Comparator

Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample

干预措施: Vancomycin (Drug)

Teicoplanin

Active Comparator

Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample

干预措施: Teicoplanin (Drug)

Linezolid

Active Comparator

Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample

干预措施: Linezolid (Drug)

结局指标

主要结局

Concentration of antibiotics in cerebrospinal fluid

时间窗: 1, 2, 4, 6, 12 hours

Concentration in CSF past i.v. injection

次要结局

未报告次要终点

研究者

发起方

Aarhus University Hospital

申办方类型

Other

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