Back to results

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

Primary Purpose

Central Nervous System Infections

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Meropenem

About this trial

This is an interventional treatment trial for Central Nervous System Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Meropenem

Arm Description

Meropenem i.v.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02506686

First Posted

July 17, 2015

Last Updated

July 21, 2015

Sponsor

Huashan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02506686

Brief Title

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

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

4. Oversight

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Nervous System Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Meropenem

Arm Type

Experimental

Arm Description

Meropenem i.v.

Intervention Type

Drug

Intervention Name(s)

Meropenem

Other Intervention Name(s)

Mero

Intervention Description

Meropenem i.v.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jufang Wu, MD

Organizational Affiliation

Huashan Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

27572392

Citation

Lu C, Zhang Y, Chen M, Zhong P, Chen Y, Yu J, Wu X, Wu J, Zhang J. Population Pharmacokinetics and Dosing Regimen Optimization of Meropenem in Cerebrospinal Fluid and Plasma in Patients with Meningitis after Neurosurgery. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6619-6625. doi: 10.1128/AAC.00997-16. Print 2016 Nov.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs