Vancomycin Study: Treatment of Catheter Related Bloodstream Infection Caused by Coagulase Negative Staphylococcus

University of British Columbia

Status

Completed

Conditions

Staphylococcal Infections

Treatments

Drug: Vancomycin

Study type

Interventional

Funder types

Other

Identifiers

NCT00175370

C00-0106

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients admitted to the ICU who require treatment for suspected or documented intravascular device associated (IVDA) bacteremia due to coagulase-negative staphylococci (CNS). Suspected IVDA bacteremia due to CNS is defined as finding of gram positive cocci in blood in a patient with either an intravascular device (IVD) in situ or within 24 hours of catheter removal, with clinical signs of sepsis:
- two signs of systemic inflammatory response syndrome (SIRS): heart rate (HR) > 90, Temp > 38 or < 36, white blood cell (WBC) > 12 or < 4, respiratory rate (RR) > 20 or pCO2 < 32; and
- with no obvious source of bacteremia other than the IVD.

Exclusion criteria