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

Sponsor
Huashan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02506686
Collaborator
(none)
82
Enrollment
1
Arm
15
Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Meropenem Penetration Across Blood-Brain Barrier in Patients With Central Nervous System Infection After Neurosurgery and Optimization of Meropenem Treatment
Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Dec 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Meropenem

Meropenem i.v.

Drug: Meropenem
Meropenem i.v.
Other Names:
  • Mero

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Huashan Hospital

    Investigators

    • Principal Investigator: Jufang Wu, MD, Huashan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jufang Wu, Professor, Huashan Hospital
    ClinicalTrials.gov Identifier:
    NCT02506686
    Other Study ID Numbers:
    • MERO0001
    First Posted:
    Jul 23, 2015
    Last Update Posted:
    Jul 23, 2015
    Last Verified:
    Jul 1, 2015
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Central Nervous System Infections
    Meropenem

    Study Results

    No Results Posted as of Jul 23, 2015