Study of Antibiotics in Cerebrospinal Fluid Following Intravenous Injection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Aarhus University Hospital.
Recruitment status was  Not yet recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antibiotics, Antitubercular
Linezolid
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014