Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection - Full Text View

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:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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:

Primary Outcome Measures:

Concentration of antibiotics in cerebrospinal fluid [ Time Frame: 1, 2, 4, 6, 12 hours ] [ Designated as safety issue: No ]
Conc in CSF past i.v. injection
Concentration of antibiotics in cerebrospinal fluid [ Time Frame: 1, 2, 4, 6, 12 hours ] [ Designated as safety issue: No ]
Concentration in CSF past i.v. injection

Estimated Enrollment:	30
Study Start Date:	September 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Vancomycin Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample	Drug: Vancomycin Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample
Active Comparator: Teicoplanin Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample	Drug: Teicoplanin Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample
Active Comparator: Linezolid 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:	Morten Gustav Poulsen, MD, Aarhus University Hospital, Aarhus Hospital
ClinicalTrials.gov Identifier:	NCT00925093 History of Changes
Other Study ID Numbers:	AUH-MGP-AB-CSV-2009-1
Study First Received:	June 18, 2009
Last Updated:	June 23, 2011
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:

Anti-Bacterial Agents
Vancomycin
Teicoplanin
Linezolid
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012