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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02506686

Enrollment

Registered

2015-07-23

Start date

2008-09-30

Completion date

2009-12-31

Last updated

2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Infections

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.

Interventions

DRUGMeropenem

Meropenem i.v.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026