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

Fudan University

Status and phase: Completed; Phase 4

Conditions: Central Nervous System Infections

Treatments: Drug: Meropenem

Study type: Interventional

Funder types: Other

Identifiers

NCT02506686

MERO0001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

Meropenem

Experimental group

Description:

Meropenem i.v.

Treatment:

Drug: Meropenem