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

Study Overview
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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).

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.

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

Conditions
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Central Nervous System Infections

Intervention / Treatment
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* Drug: Meropenem


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meropenem<br>Meropenem i.v. | Drug: Meropenem<br>* Meropenem i.v.<br>* Other names: Mero;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of meropenem in plasma and CSF in patients with CNS Infections | 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 | Up to 12 months |