Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175370
Status:
COMPLETED
Last Update Posted:
2008-06-20
First Post:
2005-09-09
Brief Title:
Vancomycin Study Treatment of Catheter Related Bloodstream Infection Caused by Coagulase Negative Staphylococcus
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Treatment of Catheter Related Bloodstream Infection Caused by Coagulase Negative Staphylococcus Removal of Catheter Followed by 2 Days Compared With 7 Days Intravenous Vancomycin
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients admitted into the Intensive Care Unit ICU have an intravenous IV catheter small plastic tube placed in their vein Very occasionally 4 times out of 100 the insertion of an intravenous catheter may cause an infection in the blood It has been shown that the removal of the catheter and the insertion of a new one at a new site helps to get rid of this infection Sometimes antibiotics are also given
Vancomycin is the antibiotic given intravenously into the vein to treat these catheter-related infections At Vancouver General Hospital some physicians may not give any vancomycin at all whereas others may treat with intravenous IV vancomycin for one to fourteen days
Since there are a lack of data to support the length of IV vancomycin therapy the investigators would like to find out if two days of IV vancomycin are as good as seven days
Therefore the purpose of this study is to determine if two days of IV vancomycin are as good as seven days for the treatment of catheter-related infections in the blood
Vancomycin is the antibiotic given intravenously into the vein to treat these catheter-related infections At Vancouver General Hospital some physicians may not give any vancomycin at all whereas others may treat with intravenous IV vancomycin for one to fourteen days
Since there are a lack of data to support the length of IV vancomycin therapy the investigators would like to find out if two days of IV vancomycin are as good as seven days
Therefore the purpose of this study is to determine if two days of IV vancomycin are as good as seven days for the treatment of catheter-related infections in the blood
Detailed Description:
INTRODUCTION Intravascular device associated bacteremia due to coagulase negative staphylococcus has become the most common nosocomial bacteremia Despite its prevalence no prospective study has investigated how these infections should be treated Removal of the intravascular device is associated with a reduction in recurrence rate from 20 to 3 but the required duration of vancomycin therapy is not known We propose to test the hypothesis that following removal of the intravascular device treatment with 2 days of vancomycin is equivalent to 7 days of vancomycin
INTERVENTION Randomized double-blind equivalence trial to test the hypothesis that 2 days is equivalent to 7 days of vancomycin treatment for intravascular device associated bacteremia due to coagulase negative staphylococcus The definitions for the surveillance of intravascular device associated bacteremia from the Laboratory Centre for Disease Control-Health Canada will be used
MEASUREMENTS Surveillance blood cultures on days 4 and 9 following removal of intravascular device Relatedness of strains will be determined by pulsed-field gel electrophoresis PFGE
INTERVENTION Randomized double-blind equivalence trial to test the hypothesis that 2 days is equivalent to 7 days of vancomycin treatment for intravascular device associated bacteremia due to coagulase negative staphylococcus The definitions for the surveillance of intravascular device associated bacteremia from the Laboratory Centre for Disease Control-Health Canada will be used
MEASUREMENTS Surveillance blood cultures on days 4 and 9 following removal of intravascular device Relatedness of strains will be determined by pulsed-field gel electrophoresis PFGE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None