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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01287832
Recruitment Status : Terminated (Low patient enrollment)
First Posted : February 1, 2011
Results First Posted : January 17, 2014
Last Update Posted : February 10, 2014
Henry Ford Health System
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
Leonard B. Johnson, St. John Health System, Michigan

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.

Condition or disease Intervention/treatment Phase
Bacteremia Drug: Vancomycin Drug: Daptomycin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: High dose vancomycin
Vancomycin dosed to achieve a trough of 15-20 microgram/mL.
Drug: Vancomycin
Vancomycin dosed to achieve a trough of 15-20 microgram/mL.

Experimental: High-dose daptomycin
Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
Drug: Daptomycin

Primary Outcome Measures :
  1. Number of Participants With Clinical Success at Test of Cure Visit. [ Time Frame: 30-42 days post-treatment ]
    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 :
  1. Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity [ Time Frame: 30-42 days post-treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Leonard B. Johnson, Division Chief, St. John Health System, Michigan Identifier: NCT01287832     History of Changes
Other Study ID Numbers: SJ1210-01
IND 109,614 ( Other Identifier: FDA )
First Posted: February 1, 2011    Key Record Dates
Results First Posted: January 17, 2014
Last Update Posted: February 10, 2014
Last Verified: January 2014

Keywords provided by Leonard B. Johnson, St. John Health System, Michigan:
Staphylococcus aureus

Additional relevant MeSH terms:
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents