Treatment Algorithm to Reduce the Use of Vancomycin in Adults With Blood Stream Infection
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
Estimated Completion Date
- Drug: Vancomycin
- Infectious Disease: Antimicrobials,Cardiovascular
- Pharmacy: Antimicrobials
- Staphylococcal Infections
Duke University -- 00025497
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
- 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.
1. Has known or suspected new complicated staphylococcal infection at the time of
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
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
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 Âµg/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
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
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
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.
18 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (24)
|Albert Einstein College of Medicine - Bronx, New York||40.3 miles||None||None||None|
|Albert Einstein College of Medicine - Bronx, New York||40.3 miles||Paul Riska MDfirstname.lastname@example.org|
|University of Mass - Worcester, Massachusetts||117.6 miles||None||None||None|
|University of Mass - Worcester, Massachusetts||117.6 miles||Jennifer Daly MDemail@example.com|
|Brody School of Medicine at ECU - Greenville, North Carolina||449.0 miles||Paul Cook MDfirstname.lastname@example.org|
|Brody School of Medicine at ECU - Greenville, North Carolina||449.0 miles||None||None||None|
|Duke University Medical Center - Durham, North Carolina||474.1 miles||Vivian Chu MDemail@example.com|
|Duke University Medical Center - Durham, North Carolina||474.1 miles||None||None||None|
|Henry Ford Hospital - Detroit, Michigan||513.4 miles||None||None||None|
|William Beaumont Hospital - Royal Oak, Michigan||519.0 miles||None||None||None|
|William Beaumont Hospital - Royal Oak, Michigan||519.0 miles||Matthew Sims MD||248-551-0495||Matthew.Sims@beaumont.edu|
|Carolina Medical Center - Charlotte, North Carolina||586.2 miles||None||None||None|
|Carolina Medical Center - Charlotte, North Carolina||586.2 miles||James Horton MD||704-335-3823||James.Horton@carolinahealthcare.org|
|Greenville Hospital System - Greenville, South Carolina||667.6 miles||None||None||None|
|Medical University of South Carolina - Charleston, South Carolina||691.2 miles||None||None||None|
|Medical University of South Carolina - Charleston, South Carolina||691.2 miles||Dannah Wray MDfirstname.lastname@example.org|
|University of Alabama Birmingham - Birmingham, Alabama||916.1 miles||Sherree Wright RNemail@example.com|
|University of Alabama Birmingham - Birmingham, Alabama||916.1 miles||None||None||None|
|University of Nebraska Medical Center - Omaha, Nebraska||1,182.2 miles||None||None||None|
|UT MD Anderson Cancer Center - Houston, Texas||1,475.7 miles||Isam Raad MDfirstname.lastname@example.org|
|UT MD Anderson Cancer Center - Houston, Texas||1,475.7 miles||None||None||None|
|University of Colorado - Denver, Colorado||1,668.0 miles||None||None||None|
|University of Colorado - Denver, Colorado||1,668.0 miles||Timothy Jenkins MDemail@example.com|
|David Geffen School of Medicine UCLA - Los Angeles, California||2,499.3 miles||None||None||None|