DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Huashan Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Central Nervous System Infections

Intervention: Meropenem (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Huashan Hospital

Official(s) and/or principal investigator(s):
Jufang Wu, MD, Principal Investigator, Affiliation: Fudan University

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).

Clinical Details

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 design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Concentrations of meropenem in plasma and CSF in patients with CNS Infections

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: September 2008
Last updated: July 21, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017