Treatment Algorithm to Reduce the Use of Vancomycin in Adults With Blood Stream Infection

Description

The purpose of this study is to accurately determine the length of appropriate drug treatment for staphylococcal catheter associated blood stream infection. The study seeks to address important information about the management of catheter associated staphylococcal blood stream infections.

Study Start Date

February 2011

Estimated Completion Date

December 2016

Interventions

  • Drug: Vancomycin

Specialties

  • Infectious Disease: Antimicrobials,Cardiovascular
  • Pharmacy: Antimicrobials
  • Hospitalist:

MeSH Terms

  • Bacteremia
  • Staphylococcal Infections
  • Vancomycin

Study ID

Duke University -- 00025497

Status

Unknown

Trial ID

NCT01191840

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

500

Sponsor

Duke University

Inclusion Criteria

    1. Provide signed and dated informed consent. The patient's legally authorized representative (LAR) can provide a signed informed consent for the patient if allowed by local Institutional Review Board/Ethics Committee (IRB/EC) policy. 2. Is >= 18 yrs of age. 3. Has suspected or confirmed catheter associated infection as defined by the following: Confirmed catheter-associated staphylococcal blood stream infection will be defined as the isolation of staphylococci in a patient with 1) "an intravascular device and >= 1 positive blood culture of blood samples obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for bloodstream infection (with the exception of the catheter) and 2) at least one of the following: "a positive result of semiquantitative (> 15 colony forming units [cfu] per catheter segment) or quantitative (> 102 cfu per catheter segment) catheter culture, whereby the same organism (species and antibiogram) is isolated from a catheter segment and a peripheral blood sample simultaneous quantitative cultures of blood samples with a ratio of > 5:1 (central venous catheter [CVC] vs peripheral) or a differential time to positivity (i.e., a positive result of culture from a CVC is obtained at least 2 hours earlier than is a positive result of culture from peripheral blood). Suspected catheter-associated staphylococcal blood stream infection will be defined as the isolation of staphylococci in a patient with an intravascular device, or a patient who has had an intravascular device removed within 48 hours of blood culture drawn, and >= 1 positive blood culture of blood samples obtained from the peripheral vein, and clinical suspicion of catheter associated infection, but without any quantitative or semiquantitative culture confirmation as present in patients with confirmed infection. Note that:
  • Patients who have had a catheter removed for suspected infection within the 48 hours prior to blood culture drawn will be eligible.
  • Patients in whom the catheter is still in place at the time of enrollment must agree to have the catheter removed within 48 hours. 4. Has blood stream infection defined as at least one positive blood culture for Staphylococcus aureus (S. Aureus) or Coagulase Negative Staphylococci(CoNS), obtained within 2 calendar days prior to the first dose of study medication (Day 2 or Day -1). Among patients being evaluated for study enrollment prior to speciation of the bacteria isolated from blood cultures, a Gram stain result of blood culture contents demonstrating Gram positive cocci in clusters will be acceptable. 5. Subject requires intravenous antibiotic therapy in the opinion of his/her physician. 6. Women of child bearing potential must have a negative urine pregnancy test. 7. All patients of reproductive potential must be abstinent or agree to use double-barrier contraception while receiving study (algorithm based or Standard of Care) therapy.

Exclusion Criteria

    1. Has known or suspected new complicated staphylococcal infection at the time of enrollment. 2. Weighs >= 200 kg. 3. Has non-removable intravascular foreign material at the time a positive blood culture was drawn (e.g., intracardiac pacemaker or cardioverter/defibrillator wires, hemodialysis access grafts, cardiac prosthetic valve, valvular support ring), which was not removed within 48 hours of enrollment. Exception: patients with epicardial pacemakers and non-hemodialysis grafts in place >90 days are eligible for enrollment). 4. Has an arthroplasty (e.g. hip, knee, or other joint prosthesis). Permitted foreign bodies include orthopedic pins, plates, or screws vascular stents in place for > 6 weeks. 5. Has a moribund clinical condition such that there is a high likelihood of death or cardiac surgery during the next three days. 6. Has shock or hypotension (supine systolic blood pressure < 80 mmHg) or oliguria (urine output < 20 mL/h) unresponsive to fluids or pressors within four hours. 7. Has received an investigational drug within 30 days of study entry. 8. Has a documented history of significant allergy or intolerance to vancomycin or protocol-approved alternate antibiotics if used. 9. Has an infecting pathogen with confirmed reduced susceptibility to vancomycin (Minimum Inhibitory Concentrations (MIC) > 2 µg/mL). Note: If reduced susceptibility to vancomycin is discovered after enrollment, the patient will be treated with daptomycin (if pathogen is susceptible). Patient will remain in study as appropriate and be evaluated in the Intent to Treat (ITT) analysis, but will be excluded from Protocol Population (PP) analyses. 10. Is severely neutropenic (absolute neutrophil count < 0.500x103/mm3) or is anticipated to develop severe neutropenia (absolute neutrophil count < 0.500x103/ mm3 ) during the study treatment period due to prior or planned chemotherapy. 12. Has previously known Human Immunodeficiency Virus (HIV) infection with a history of Acquired Immune Deficiency Syndrome (AIDS) defining illness. 13. Is considered unlikely to comply with study procedures or to return for scheduled post-treatment evaluations. 14. Is pregnant or trying to get pregnant, nursing, or lactating. 15. Has known or suspected septic arthritis, osteomyelitis, pneumonia or other metastatic focus of infection. 16. Has polymicrobial blood stream infection. Note that it is possible that a subject may not have a known polymicrobial bloodstream infection at the time of enrollment, but additional pathogen(s) can subsequently be isolated from the initial blood culture. These patients will be eligible to remain in this trial. 17. Hospitalization for staphylococcal infection within the past 12 months. 18. Is hemodialysis dependent or has end stage renal disease (Creatinine Clearance (CrCl) < 30 cc/min). 19. Developed Staphylococcus aureus blood stream infection within 72 hours of percutaneous coronary revascularization 20. Received of any of the following antibiotics for 7 or more of the 10 calendar days immediately preceding the calendar day that the initial positive blood culture was drawn:
  • If methicillin susceptibility of the isolate is unknown at the time of enrollment: vancomycin
  • daptomycin telavancin tigecycline linezolid (in either oral or intravenous administration) quinupristin/dalfopristin piperacillin/tazobactam nafcillin oxacillin cloxacillin cefazolin ceftriaxone ceftaroline levofloxacin or equivalent fluoroquinolone (in either oral or intravenous administration) Note: ciprofloxacin is not an exclusion criteria.
  • If the staphylococcal isolate is known to be methicillin resistant: vancomycin
  • daptomycin telavancin tigecycline linezolid (in either oral or intravenous administration), quinupristin/dalfopristin, ceftaroline. 21. Has previously participated in this study.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (24)

Study Location Distance Name Phone Email
University of Mass - Worcester, Massachusetts 22.9 miles None None None
University of Mass - Worcester, Massachusetts 22.9 miles Jennifer Daly MD 508-856-4060 jennifer.daly@umassmemorial.org
Albert Einstein College of Medicine - Bronx, New York 176.6 miles None None None
Albert Einstein College of Medicine - Bronx, New York 176.6 miles Paul Riska MD 718-920-6494 priska@montefiore.org
Brody School of Medicine at ECU - Greenville, North Carolina 577.7 miles Paul Cook MD 252-744-4500 cookp@ecu.edu
Brody School of Medicine at ECU - Greenville, North Carolina 577.7 miles None None None
Duke University Medical Center - Durham, North Carolina 608.4 miles Vivian Chu MD 919-668-7174 vivian.chu@duke.edu
Duke University Medical Center - Durham, North Carolina 608.4 miles None None None
Henry Ford Hospital - Detroit, Michigan 612.3 miles None None None
William Beaumont Hospital - Royal Oak, Michigan 616.2 miles None None None
William Beaumont Hospital - Royal Oak, Michigan 616.2 miles Matthew Sims MD 248-551-0495 Matthew.Sims@beaumont.edu
Carolina Medical Center - Charlotte, North Carolina 721.9 miles None None None
Carolina Medical Center - Charlotte, North Carolina 721.9 miles James Horton MD 704-335-3823 James.Horton@carolinahealthcare.org
Greenville Hospital System - Greenville, South Carolina 803.9 miles None None None
Medical University of South Carolina - Charleston, South Carolina 821.2 miles None None None
Medical University of South Carolina - Charleston, South Carolina 821.2 miles Dannah Wray MD 843-792-4541 wraydw@musc.edu
University of Alabama Birmingham - Birmingham, Alabama 1,052.1 miles Sherree Wright RN 205-934-2186 sherree@uab.edu
University of Alabama Birmingham - Birmingham, Alabama 1,052.1 miles None None None
University of Nebraska Medical Center - Omaha, Nebraska 1,283.6 miles None None None
UT MD Anderson Cancer Center - Houston, Texas 1,609.9 miles Isam Raad MD 713-792-7943 iraad@mdanderson.org
UT MD Anderson Cancer Center - Houston, Texas 1,609.9 miles None None None
University of Colorado - Denver, Colorado 1,769.5 miles None None None
University of Colorado - Denver, Colorado 1,769.5 miles Timothy Jenkins MD 303-602-5041 timothy.jenkins@dhha.org
David Geffen School of Medicine UCLA - Los Angeles, California 2,605.2 miles None None None

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