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

NCT00175370 | Completed

• 1 other identifier: C00-0106
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcal Infections

Keywords

Vancomycin; Coagulase Negative Staphylococcus; Central Venous Catheter; Bloodstream infection; CNS bloodstream infection

Outcome Measures

Primary Outcomes (3)

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

  Nine days

• Early bacteriologic failure

  Nine days

• 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

  Nine days

Secondary Outcomes (1)

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

  Nine days

Interventions

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).

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital Intensive Care Unit

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Staphylococcal Infections; Sepsis

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jane de Lemos, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2000
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 20, 2008

Record last verified: 2008-06

Locations

CA (1)