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

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ClinicalTrials.gov Identifier: NCT00175370
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : June 20, 2008
Sponsor:
Information provided by:
University of British Columbia

Study Description
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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.


Condition or disease Intervention/treatment Phase
Staphylococcal Infections Drug: Vancomycin Not Applicable

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).


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2000
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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Arms and Interventions
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Intervention Details:
  • Drug: Vancomycin
    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).

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. The secondary endpoint will be the proportion of patients with clinical failure, late bacteriologic failure and recurrent bacteremia. [ Time Frame: Nine days ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175370


Locations
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Canada, British Columbia
Vancouver General Hospital Intensive Care Unit
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Jane de Lemos, MD University of British Columbia
More Information
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Responsible Party: Dr. Jane de Lemos, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175370     History of Changes
Other Study ID Numbers: C00-0106
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: June 20, 2008
Last Verified: June 2008
Keywords provided by University of British Columbia:
Vancomycin
Coagulase Negative Staphylococcus
Central Venous Catheter
Bloodstream infection
CNS bloodstream infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
 Vancomycin
Coagulase
Anti-Bacterial Agents
Anti-Infective Agents
Coagulants