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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)

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: December 14, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Bacteremia
 Drug: Vancomycin vs. daptomycin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. John Health System, Michigan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: June 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High dose vancomycin Drug: Vancomycin vs. daptomycin
Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
Experimental: High-dose daptomycin Drug: Vancomycin vs. daptomycin
Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Leonard B. Johnson, Division Chief, St. John Health System, Michigan
ClinicalTrials.gov Identifier: NCT01287832     History of Changes
Other Study ID Numbers: SJ1210-01, IND 109,614
Study First Received: January 31, 2011
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by St. John Health System, Michigan:
Methicillin-resistant
Staphylococcus aureus

Additional relevant MeSH terms:
Bacteremia
Staphylococcal Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
 Gram-Positive Bacterial Infections
Methicillin
Vancomycin
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013