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OpenTrials
Completed

NCT Number: NCT02506686

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meropenem

Drug

Meropenem i.v.

Other names: Mero

Primary outcomes

  1. Concentrations of meropenem in plasma and CSF in patients with CNS Infections

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 23, 2015
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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