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

This study has been terminated.
(Low patient enrollment)
Sponsor:
Collaborators:
Henry Ford Health System
Cubist Pharmaceuticals
Information provided by (Responsible Party):
Leonard B. Johnson, St. John Health System, Michigan
ClinicalTrials.gov Identifier:
NCT01287832
First received: January 31, 2011
Last updated: January 16, 2014
Last verified: January 2014

January 31, 2011
January 16, 2014
June 2011
January 2012   (final data collection date for primary outcome measure)
Number of Participants With Clinical Success at Test of Cure Visit. [ Time Frame: 30-42 days post-treatment ] [ Designated as safety issue: Yes ]
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.
Clinical Success of High-dose Vancomycin Versus Daptomycin for Staphylococcus Aureus Bacteremia Due to Isolates With MIC > 1. [ Time Frame: 30-42 days post-treatment ] [ Designated as safety issue: Yes ]
Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy.
Complete list of historical versions of study NCT01287832 on ClinicalTrials.gov Archive Site
Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity [ Time Frame: 30-42 days post-treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bacteremia
  • Drug: Vancomycin
    Vancomycin dosed to achieve a trough of 15-20 microgram/mL.
  • Drug: Daptomycin
  • Active Comparator: High dose vancomycin
    Vancomycin dosed to achieve a trough of 15-20 microgram/mL.
    Intervention: Drug: Vancomycin
  • Experimental: High-dose daptomycin
    Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
    Intervention: Drug: Daptomycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01287832
SJ1210-01, IND 109,614
Yes
Leonard B. Johnson, St. John Health System, Michigan
St. John Health System, Michigan
  • Henry Ford Health System
  • Cubist Pharmaceuticals
Not Provided
St. John Health System, Michigan
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP