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

Phase 4

Completed

• Conditions: Central Nervous System Infections
• Interventions: Drug: Meropenem

• Registration Number: NCT02506686
• Lead Sponsor: Huashan Hospital

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 Description

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.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2015-07
• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-07-21
• Last Update Submitted: 2015-07-21
• Study First Posted: 2015-07-23
• Last Update Posted: 2015-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Meropenem	Meropenem	Meropenem i.v.

Primary Outcome Measures

Name	Time	Method
Concentrations of meropenem in plasma and CSF in patients with CNS Infections	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