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

Tracking Information
First Received Date ^ICMJE	January 31, 2011
Last Updated Date	December 14, 2012
Start Date ^ICMJE	June 2011
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 31, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01287832 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 31, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Bacteremia
Intervention ^ICMJE	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)
Study Arm (s)	Active Comparator: High dose vancomycin Intervention: Drug: Vancomycin vs. daptomycin Experimental: High-dose daptomycin Intervention: Drug: Vancomycin vs. daptomycin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	12
Completion Date	January 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01287832
Other Study ID Numbers ^ICMJE	SJ1210-01, IND 109,614
Has Data Monitoring Committee	Yes
Responsible Party	Leonard B. Johnson, St. John Health System, Michigan
Study Sponsor ^ICMJE	St. John Health System, Michigan
Collaborators ^ICMJE	Henry Ford Health System Cubist Pharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	St. John Health System, Michigan
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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