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Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

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ClinicalTrials.gov Identifier: NCT00925093
Recruitment Status : Withdrawn (Primary investigator left institution)
First Posted : June 19, 2009
Last Update Posted : January 26, 2015
Sponsor:
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment Phase
Neurosurgery Drug: Vancomycin Drug: Teicoplanin Drug: Linezolid Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Antibiotics in Cerebrospinal Fluid Following Intravenous Injection
Study Start Date : September 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Concentration of antibiotics in cerebrospinal fluid [ Time Frame: 1, 2, 4, 6, 12 hours ]
    Concentration in CSF past i.v. injection


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
More Information

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
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: June 2009

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
Linezolid
Teicoplanin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action