NCT00925093

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).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2011

Typical duration for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2009

Completed
2.2 years until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 26, 2015

Status Verified

June 1, 2009

Enrollment Period

1.3 years

First QC Date

June 18, 2009

Last Update Submit

January 23, 2015

Conditions

Neurosurgery

Keywords

vancomycinteicoplaninlinezolidintravenouscerebrospinal fluidCSFpharmacokineticspenetrationblood-brain barrierPharmacokinetics of three antibiotics in relation to cerebrospinal fluid

Outcome Measures

Primary Outcomes (1)

  • Concentration of antibiotics in cerebrospinal fluid

    Concentration in CSF past i.v. injection

    1, 2, 4, 6, 12 hours

Study Arms (3)

Vancomycin

ACTIVE COMPARATOR

Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample

Drug: Vancomycin

Teicoplanin

ACTIVE COMPARATOR

Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample

Drug: Teicoplanin

Linezolid

ACTIVE COMPARATOR

Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample

Drug: Linezolid

Interventions

VancomycinDRUG

Vancomycin is administered intravenously and subsequently measured in cerebrospinal fluid sample

Vancomycin
TeicoplaninDRUG

Teicoplanin is administered intravenously and subsequently measured in cerebrospinal fluid sample

Teicoplanin
LinezolidDRUG

Linezolid is administered intravenously and subsequently measured in cerebrospinal fluid sample

Linezolid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old
  • Already having an external CSF drain
  • Scheduled for neurosurgery requiring antibiotic prophylaxis (most commonly placement of an internal drain ("shunt")

You may not qualify if:

  • Infection or colonization requiring other than standard prophylactic antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

VancomycinTeicoplaninLinezolid

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsLipoglycopeptidesAcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2009

First Posted

June 19, 2009

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

January 26, 2015

Record last verified: 2009-06