Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

This study is not yet open for participant recruitment.

Verified June 2009 by Aarhus University Hospital

Sponsor:

Information provided by:

Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT00925093

First received: June 18, 2009

Last updated: June 23, 2011

Last verified: June 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	June 18, 2009
Last Updated Date	June 23, 2011
Start Date ^ICMJE	September 2011
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2011)	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
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00925093 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection
Official Title ^ICMJE	Antibiotics in Cerebrospinal Fluid Following Intravenous Injection
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Neurosurgery
Intervention ^ICMJE	Drug: Vancomycin Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample Drug: Teicoplanin Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample Drug: Linezolid Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample
Study Arm (s)	Active Comparator: Vancomycin Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample Intervention: Drug: Vancomycin Active Comparator: Teicoplanin Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample Intervention: Drug: Teicoplanin Active Comparator: Linezolid Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample Intervention: Drug: Linezolid
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00925093
Other Study ID Numbers ^ICMJE	AUH-MGP-AB-CSV-2009-1
Has Data Monitoring Committee	No
Responsible Party	Morten Gustav Poulsen, MD, Aarhus University Hospital, Aarhus Hospital
Study Sponsor ^ICMJE	Aarhus University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Aarhus University Hospital
Verification Date	June 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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