NCT00362245撤回4 期
Amikacin Penetration Into the Cerebrospinal Fluid: Pharmacokinetic/Pharmacodynamic Analysis in Adults With Hospital Acquired Gram-negative Meningitis Associated With Intracranial Pressure Monitoring and Draining Devices
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Blood and CSF AUC/MIC relationship
研究概览
简要总结
The limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients.
详细描述
The limited available data precludes establishing an antibiotic regimen in patients suffering from bacterial meningitis after head trauma, or spontaneous bleeding Understanding the disposition of Amikacin administered intrathecally will enable to propose rational treatment of these patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Culture proved bacterial meningitis where the prescribed therapy includes the use of systemic and intraventricular amikacin therapy.
- •The included patient should have an intraventricular catheter placed for intraventricular pressure measurement and admitted to an intensive care unit.
- •Blood creatinine concentration up to 1.49 mg/dL measured at the inclusion day.
排除标准
- •Patients or legal guardians who refuse to participate in the study.
- •Known allergy to amikacin.
- •Blood creatinine concentration of 1.5 mg/dL or higher.
- •Subjects without intraventricular catheter who will need repeated lumbar punctures for CSF amikacin determinations.
- •Patients suffering from known chronic liver disease.
结局指标
主要结局
Blood and CSF AUC/MIC relationship
Bactericidal effect on the causative bacteria
次要结局
未报告次要终点
研究者
研究点 (2)
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