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

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ClinicalTrials.gov Identifier: NCT02506686
Recruitment Status : Completed
First Posted : July 23, 2015
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Jufang Wu, Huashan Hospital

Study Description
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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
Central Nervous System Infections Drug: Meropenem 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
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Study Type : Interventional  (Clinical Trial)
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 : September 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Meropenem

Arms and Interventions
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Arm Intervention/treatment
Experimental: Meropenem
Meropenem i.v.
 Drug: Meropenem
Meropenem i.v.
Other Name: Mero


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506686


Sponsors and Collaborators
Huashan Hospital
Investigators
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Principal Investigator: Jufang Wu, MD Huashan Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jufang Wu, Professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT02506686    
Other Study ID Numbers: MERO0001
First Posted: July 23, 2015    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Central Nervous System Infections
Disease Attributes
Pathologic Processes
 Central Nervous System Diseases
Nervous System Diseases
Meropenem
Anti-Bacterial Agents
Anti-Infective Agents