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Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

This study has been withdrawn prior to enrollment.
(Primary investigator left institution)
Sponsor:
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00925093
First received: June 18, 2009
Last updated: January 23, 2015
Last verified: June 2009

June 18, 2009
January 23, 2015
September 2011
December 2012   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00925093 on ClinicalTrials.gov Archive Site
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Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection
Antibiotics in Cerebrospinal Fluid Following Intravenous Injection
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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Neurosurgery
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00925093
AUH-MGP-AB-CSV-2009-1
No
Not Provided
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Morten Gustav Poulsen, MD, Aarhus University Hospital, Aarhus Hospital
Aarhus University Hospital
Not Provided
Not Provided
Aarhus University Hospital
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP