Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

Phase 1

Withdrawn

• Conditions: Neurosurgery
• Interventions: Drug: Linezolid; Drug: Vancomycin; Drug: Teicoplanin

• Registration Number: NCT00925093
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Three different antibiotics are used to prevent infection in case of neurosurgery - this study examines to which extent the antibiotics penetrate from the blood to the cerebrospinal fluid (surrounding the brain).

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-06
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-18
• Study First Posted: 2009-06-19
• Study Start: 2011-09
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Last Update Submitted: 2015-01-23
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Over 18 years old
• Already having an external CSF drain
• Scheduled for neurosurgery requiring antibiotic prophylaxis (most commonly placement of an internal drain ("shunt")

Exclusion Criteria

• Infection or colonization requiring other than standard prophylactic antibiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linezolid	Linezolid	Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample
Vancomycin	Vancomycin	Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample
Teicoplanin	Teicoplanin	Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample

Primary Outcome Measures

Name	Time	Method
Concentration of antibiotics in cerebrospinal fluid	1, 2, 4, 6, 12 hours	Concentration in CSF past i.v. injection