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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
  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 1

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
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 May 21, 2013