Evaluation of Meropenem Penetration Across Blood-Brain Barrier in Patients With Central Nervous System Infection After Neurosurgery and Optimization of Meropenem Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Concentrations of meropenem in plasma and CSF in patients with CNS Infections
研究概览
简要总结
A prospective, open-label study investigated the pharmacokinetic profile of meropenem in patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB penetration into cerebrospinal fluid (CSF).
详细描述
Meropenem is important for management of post-neurosurgical meningitis, but the data about its penetration across blood-brain barrier (BBB) are inadequate. This prospective, open-label study investigated the pharmacokinetic profile of meropenem in patients with post-neurosurgical central nervous system (CNS) infection, especially its BBB penetration into cerebrospinal fluid (CSF). A total of 82 patients with post-neurosurgical CNS infection were included to receive meropenem intravenously according to regimen of 2g q8h, 1g q8h or 1g q6h. After infusion of 4 doses, blood and CSF samples were collected simultaneously at predefined timepoints. High-performance liquid chromatography ultraviolet method was used to determine the concentration of meropenem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years of age
- •requiring continuous drainage of CSF or gram-negative bacteria were identified from CSF culture
- •have temperature fever (T > 37.5℃)
- •have signs of meningeal irritation
- •white blood cells in CSF > 300 × 10^6/L
排除标准
- •hypersensitive to meropenem
- •did not receive at least 3 days of meropenem treatment
- •are receiving hemodialysis
- •unstable vital signs
- •have lumbar puncture contraindications and so inappropriate for sample collection
- •severe hepatic or renal dysfunction
- •status epilepticus
- •potential neurodegenerative diseases
- •pregnancy
- •breast-feeding
研究组 & 干预措施
Meropenem
Meropenem i.v.
干预措施: Meropenem (Drug)
结局指标
主要结局
Concentrations of meropenem in plasma and CSF in patients with CNS Infections
时间窗: Up to 12 months
The concentrations of meropenem in plasma and CSF in patients with post-neurosurgical CNS after administration of three different dosing regimens of meropenem at each time points by HPLC-UV
次要结局
未报告次要终点