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Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)

Primary Purpose

Bacteremia

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Vancomycin
Daptomycin
Sponsored by
St. John Health System, Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacteremia focused on measuring Methicillin-resistant, Staphylococcus aureus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Signed informed consent
  • All cases of suspected MRSA bacteremia as determined by a patient with at least one blood culture growing gram-positive cocci in clusters with a clinical syndrome consistent with true bacteremia including fever, hypothermia (temperature < 36.0º C), tachycardia (heart rate > 100 beats/minute), hypotension (systolic blood pressure < 90 mm Hg) or other clinical features of sepsis.
  • All cases of right-sided native valve endocarditis due to MRSA
  • Patients who are diagnosed with left-sided native valve endocarditis after randomization will be continued in the study
  • Patients with MRSA bacteremia associated with infected foreign bodies, including vascular prostheses, orthopedic prostheses

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    High dose vancomycin

    High-dose daptomycin

    Arm Description

    Vancomycin dosed to achieve a trough of 15-20 microgram/mL.

    Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)

    Outcomes

    Primary Outcome Measures

    Number of Participants With Clinical Success at Test of Cure Visit.
    Clinical success is the absence of treatment failures. Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy.

    Secondary Outcome Measures

    Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity

    Full Information

    First Posted
    January 31, 2011
    Last Updated
    January 16, 2014
    Sponsor
    St. John Health System, Michigan
    Collaborators
    Henry Ford Health System, Cubist Pharmaceuticals LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01287832
    Brief Title
    Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Terminated
    Why Stopped
    Low patient enrollment
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    January 2012 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. John Health System, Michigan
    Collaborators
    Henry Ford Health System, Cubist Pharmaceuticals LLC

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    There is an increased failure rate for the treatment of Staphylococcus Aureus Bacteremia (SAB) with traditional doses of vancomycin, the standard of care for patients with MRSA bacteremia over the last 40 years. This has been largely attributed to isolates with increased resistance to vancomycin (increased MIC). Daptomycin is an antibiotic that was approved several years ago for the treatment of SAB and is being increasingly used for MRSA bacteremia due to isolates with increased MIC. Increased doses have been recommended for both of these drugs in the treatment of this infection without a trial demonstrating their relative efficacy or safety at higher doses. This study will randomize patients with SAB due to MRSA with an increased MIC to determine the relative efficacy and safety of vancomycin and daptomycin used at higher than traditional doses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacteremia
    Keywords
    Methicillin-resistant, Staphylococcus aureus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    High dose vancomycin
    Arm Type
    Active Comparator
    Arm Description
    Vancomycin dosed to achieve a trough of 15-20 microgram/mL.
    Arm Title
    High-dose daptomycin
    Arm Type
    Experimental
    Arm Description
    Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
    Intervention Type
    Drug
    Intervention Name(s)
    Vancomycin
    Intervention Description
    Vancomycin dosed to achieve a trough of 15-20 microgram/mL.
    Intervention Type
    Drug
    Intervention Name(s)
    Daptomycin
    Primary Outcome Measure Information:
    Title
    Number of Participants With Clinical Success at Test of Cure Visit.
    Description
    Clinical success is the absence of treatment failures. Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy.
    Time Frame
    30-42 days post-treatment
    Secondary Outcome Measure Information:
    Title
    Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity
    Time Frame
    30-42 days post-treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older Signed informed consent All cases of suspected MRSA bacteremia as determined by a patient with at least one blood culture growing gram-positive cocci in clusters with a clinical syndrome consistent with true bacteremia including fever, hypothermia (temperature < 36.0º C), tachycardia (heart rate > 100 beats/minute), hypotension (systolic blood pressure < 90 mm Hg) or other clinical features of sepsis. All cases of right-sided native valve endocarditis due to MRSA Patients who are diagnosed with left-sided native valve endocarditis after randomization will be continued in the study Patients with MRSA bacteremia associated with infected foreign bodies, including vascular prostheses, orthopedic prostheses

    12. IPD Sharing Statement

    Learn more about this trial

    Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)

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