Trial record 1 of 1 for:    NCT01191840
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Treatment Algorithm to Reduce the Use of Vancomycin in Adults With Blood Stream Infection (Bacteremia)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01191840
First received: August 28, 2010
Last updated: June 3, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Bacteremia
Drug: Vancomycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Open-Label, Comparative Study to Assess the Safety and Efficacy of a Treatment Algorithm to Reduce the Use of Vancomycin in Adult Patients With Blood Stream Infections Due to Staphylococci

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Compare cure rate between algorithm and standard of care therapy [ Time Frame: 28-42 days after last dose of antibiotics ] [ Designated as safety issue: No ]
    To compare the cure rate at Test of Cure evaluation, between the proposed treatment algorithm and the standard of care therapy.

  • Evaluate safety of algorithm-based therapy [ Time Frame: 28-42 days after last dose of antibiotic ] [ Designated as safety issue: Yes ]
    To evaluate the safety of algorithm-based therapy as an alternative to current standard of care.


Secondary Outcome Measures:
  • Antibiotic days by treatment group [ Time Frame: 28-42 days after last dose of antibiotic ] [ Designated as safety issue: No ]
    This will be analyzed by evaluating the difference in antibiotic days by treatment group and calculating 95% confidence intervals around the difference in antibiotic days among study patients randomized to algorithm-based treatment vs. among study patients randomized to standard treatment.


Estimated Enrollment: 500
Study Start Date: February 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Algorithm-determined therapy Drug: Vancomycin
Duration
Other Names:
  • Nafcillin
  • Oxacillin
  • Cloxacillin
  • Daptomycin
  • Cefazolin
Active Comparator: Standard of Care Drug: Vancomycin
Duration
Other Names:
  • Nafcillin
  • Oxacillin
  • Cloxacillin
  • Daptomycin
  • Cefazolin

Detailed Description:

To demonstrate that the clinical efficacy of algorithm-based therapy of patients with staphylococcal blood stream infection is noninferior to current standard of care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. If the subject has an intravenous catheter in place then the subject and his/her primary health care provider must agree to have the catheter removed within 5 days of the initial blood culture draw with the exception of those subjects who meet criteria for simple CoNS bacteremia as defined in Table 1. The catheter may be retained in those subjects with simple CoNS bacteremia.
  4. Has blood stream infection defined as at least one blood culture positive for S. aureus or CoNS. In most cases, vancomycin(or other study drug alternative) will have been started prior to randomization. Enrollment windows depend on speciation and clinical classification as follows:

    1. speciation of CoNS and classification as simple per Table 1-must be randomized within 3 calendar days of the start of treatment effective for the baseline infecting pathogen
    2. speciation of CoNS and classification as uncomplicated per Table 1 must be randomized within 4 calendar days of the start of treatment effective for the baseline infecting pathogen
    3. speciation of S. aureus - must be randomized within 12 calendar days of the start of treatment effective for the baseline infecting pathogen
  5. This criterion has been removed
  6. Women of child bearing potential must have a negative urine and/or serum 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). Exception: coronary stents, inferior vena cava (IVC) filters, patients with pacemakers whose baseline infecting pathogen is a CoNS, vascular stents in place for > 6 weeks, non-hemodialysis grafts in place >90 days and hemodialysis grafts not used within past 12 months and not previously infected are eligible for randomization. Arthroplasties and other extravascular devices, e.g. synthetic hernia repair mesh, and non-arthroplasty orthopedic prostheses including pins or plates, are acceptable as long as there are no signs or symptoms of foreign material-related infection at the time of randomization.
  4. This criterion has been removed
  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 antibacterial agent with anti-staphylococcal activity within 30 days prior to randomization.
  8. Has a documented history of significant allergy or intolerance to all protocol-approved antibiotics anticipated to be effective for their infection.
  9. Has an infecting pathogen with confirmed reduced susceptibility to vancomycin (Minimum Inhibitory Concentrations (MIC) > 2 µg/mL) if known. 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. For S. Aureus patients, is severely neutropenic (absolute neutrophil count < 0.100x103/mm3) or is anticipated to develop severe neutropenia (absolute neutrophil count < 0.100x103/ mm3) during the study treatment period due to prior or planned chemotherapy. CoNS patients with neutropenia are eligible to be enrolled.
  11. This criterion has been removed
  12. Has previously known Human Immunodeficiency Virus (HIV) infection with a nadir CD4+ count of <100 cells/mm3 within the past 12 months
  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. CoNS patients with pneumonia and not being treated or anticipated to start treatment with anti-biotics effective for the baseline infecting pathogen can be included
  16. Has polymicrobial blood stream infection including at least one non-staphylococcal species, except AFTER consultation with the Clinical Medical Monitor at DCRI. Note that it is possible that a subject may not have a known polymicrobial bloodstream infection at the time of randomization, but additional pathogen(s) can subsequently be isolated from the initial blood culture. These patients will be eligible to remain in the trial. Please also note that patients with S. aureus plus CoNS will follow the treatment pathway for S. aureus.
  17. This criterion has been removed.
  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:

    1. If methicillin susceptibility of the isolate is unknown at the time of enrollment: vancomycin; daptomycin; telavancin; tigecycline; linezolid (in either oral or IV administration); quinupristin/dalfopristin; piperacillin/tazobactam; penicillin; nafcillin; oxacillin; cloxacillin; cefazolin, ceftriaxone, ceftaroline, levofloxacin or equivalent fluroquinolone (in either oral or IV administration) Note: ciprofloxacin is not an exclusion criteria.
    2. If the staphylococcal isolate is known to be methicillin resistant: vancomycin; daptomycin; telavancin; tigecycline; linezolid (in either oral or IV administration), quinupristin/dalfopristin, ceftaroline.

    Note: patients who have developed bacteremia after at least 7 days of prophylaxis with oral antibiotics have by definition failed prophylaxis and the oral antibiotic can be deemed non-effective for the index bacteremia. Oral antibiotics that have failed as prophylaxis in this manner will not be considered exclusionary or count towards the number of antibiotic days but must be stopped upon randomization

  21. Has previously participated in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191840

Contacts
Contact: Suzanne Aycock, MSN, PMP 919-668-8046 suzanne.aycock@duke.edu
Contact: Edward Hess, RN 919-668-6959 edward.hess@duke.edu

Locations
United States, Alabama
University of Alabama, Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Sherree Wright, RN    205-934-2186    sherree@uab.edu   
Principal Investigator: John Baddley, MD         
United States, California
David Geffen School of Medicine UCLA Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Zachary Rubin, MD    910-794-0187    ZRubin@mednet.ucla.edu   
Principal Investigator: Zachary Rubin, MD         
San Francisco General Hospital Not yet recruiting
San Francisco, California, United States, 94110
Contact: Henry Chambers, MD    415-206-5437    hchambers@medsfgh.ucsf.ed   
Principal Investigator: Henry Chambers, MD         
United States, Colorado
University of Colorado Not yet recruiting
Denver, Colorado, United States, 80204
Contact: Timothy Jenkins, MD    303-602-5041    timothy.jenkins@dhha.org   
Principal Investigator: Timothy Jenkins, MD         
United States, Massachusetts
University of Mass Recruiting
Worcester, Massachusetts, United States, 01752
Contact: Jennifer Daly, MD    508-856-4060    jennifer.daly@umassmemorial.org   
Principal Investigator: Jennifer Daly, MD         
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Donald Levine, MD    313-745-2840    dlevine@med.wayne.edu   
Principal Investigator: Donald Levine, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Marcus Zervos, MD    313-916-2573    mzervos1@hfhs.org   
Principal Investigator: Marcus Zervos, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Jennifer Cavalieri    402-559-3243    rcavalieri@unmc.edu   
Principal Investigator: Mark Rupp, MD         
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10467
Contact: Paul Riska, MD    718-920-6494    priska@montefiore.org   
Principal Investigator: Paul Riska, MD         
United States, North Carolina
Carolina Medical Center Recruiting
Charlotte, North Carolina, United States, 28207
Contact: James Horton, MD    704-335-3823    James.Horton@carolinahealthcare.org   
Principal Investigator: James Horton, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Vivian Chu, MD    919-668-7174    vivian.chu@duke.edu   
Principal Investigator: Vivian Chu, MD         
Brody School of Medicine at ECU Not yet recruiting
Greenville, North Carolina, United States, 27834
Contact: Paul Cook, MD    252-744-4500    cookp@ecu.edu   
Principal Investigator: Paul Cook, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Dannah Wray, MD    843-792-4541    wraydw@musc.edu   
Principal Investigator: Dannah Wray, MD         
Greenville Hospital System Recruiting
Greenville, South Carolina, United States, 29605
Contact: Isabel Gillespie    864-455-9025    igillespie@ghs.org   
Principal Investigator: John Schrank, MD         
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Isam Raad, MD    713-792-7943    iraad@mdanderson.org   
Principal Investigator: Isam Raad, MD         
Spain
Fundacio Clinic Privada per a la Recera Recruiting
Barcelona, Spain, 08036
Contact: Ana Del Rio    +34-93-227-5400    miro97@fundsoriano.es   
Principal Investigator: Jose M Miro, MD, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Vance Fowler, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01191840     History of Changes
Other Study ID Numbers: Pro00025497, DMID Protocol Number: 09-0080
Study First Received: August 28, 2010
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration
Spain: Ethics Committee

Keywords provided by Duke University:
staphylococci

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Cefazolin
Cloxacillin
Nafcillin
Oxacillin
Vancomycin
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014