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

Central Nervous System Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506686
• Other study ID #: MERO0001
• Status: Completed
• Phase: Phase 4
• First received: July 17, 2015
• Last updated: July 21, 2015
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: July 2015
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Infections
• Communicable Diseases
• Infection

Intervention

Drug:
• Meropenem
Meropenem i.v.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 12 months