This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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This study has been withdrawn prior to enrollment.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
  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
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 ]
    Concentration in CSF past i.v. injection


Enrollment: 0
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   (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
  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

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: January 23, 2015

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

ClinicalTrials.gov processed this record on June 23, 2017