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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Central Nervous System Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Meropenem

Meropenem i.v.

Group Type EXPERIMENTAL

Meropenem

Intervention Type DRUG

Meropenem i.v.

Interventions

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Meropenem

Meropenem i.v.

Intervention Type DRUG

Other Intervention Names

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Mero

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No