Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

This study is not yet open for participant recruitment.

Verified by Aarhus University Hospital, June 2009

First Received: June 18, 2009 No Changes Posted

Sponsor:	Aarhus University Hospital
Information provided by:	Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT00925093

Purpose

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).

Condition	Intervention	Phase
Neurosurgery	Drug: Vancomycin Drug: Teicoplanin Drug: Linezolid	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Teicoplanin Linezolid Vancomycin Vancomycin hydrochloride

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Estimated Enrollment:	30
Study Start Date:	September 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Vancomycin: Active Comparator Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample	Drug: Vancomycin Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample
Teicoplanin: Active Comparator Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample	Drug: Teicoplanin Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample
Linezolid: Active Comparator Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample	Drug: Linezolid Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Aarhus University Hospital, Aarhus Hospital ( Morten Gustav Poulsen, MD )
Study ID Numbers:	AUH-MGP-AB-CSV-2009-1
Study First Received:	June 18, 2009
Last Updated:	June 18, 2009
ClinicalTrials.gov Identifier:	NCT00925093 History of Changes
Health Authority:	Denmark: National Board of Health

Keywords provided by Aarhus University Hospital:

vancomycin
teicoplanin
linezolid
intravenous
cerebrospinal fluid

CSF
pharmacokinetics
penetration
blood-brain barrier
Pharmacokinetics of three antibiotics in relation to cerebrospinal fluid

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Anti-Bacterial Agents
Teicoplanin
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Vancomycin
Enzyme Inhibitors
Linezolid
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010