Skip to main content
OpenTrials
Completed

NCT Number: NCT00175370

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Staphylococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver General Hospital Intensive Care Unit

Vancouver, British Columbia, V5Z 1M9, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Underlying valvular heart disease
  • Prosthetic valve or graft
  • A history of infectious endocarditis
  • Bone marrow transplant recipient
  • Neutropenia (< 0.5 X 10^9/L)
  • Solid organ transplant recipient
  • Known hypersensitivity to vancomycin
  • Calculated creatinine clearance < 25 ml/min

Treatment and study plan

Vancomycin

Drug

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. 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).

Primary outcomes

  1. The primary outcome measurement will be the proportion of patients with early bacteriological failure

    Time frame: Nine days

  2. Early bacteriologic failure

    Time frame: Nine days

  3. Recovery in blood culture of an isolate with same antibiogram, biotype and PFGE type as the initial bacteria, from any blood culture, up to 9 days following IVD removal

    Time frame: Nine days

Secondary outcomes

  1. The secondary endpoint will be the proportion of patients with clinical failure, late bacteriologic failure and recurrent bacteremia.

    Time frame: Nine days

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Jun 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.