Clinical Trial: Meropenem Penetration Across BBB in Patients With CNS Infection and Optimization of Meropenem Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Meropenem Penetration Across Blood-Brain Barrier in Patients With Central Nervous System Infection After Neurosurgery and Optimization of Meropenem Treatment

Brief Summary: 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).

Detailed Summary: 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.
Sponsor: Huashan Hospital

Current Primary Outcome: Concentrations of meropenem in plasma and CSF in patients with CNS Infections [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Huashan Hospital

Dates:
Date Received: July 17, 2015
Date Started: September 2008
Date Completion:
Last Updated: July 21, 2015
Last Verified: July 2015