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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)

Information source: St. John Health System, Michigan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacteremia

Intervention: Vancomycin (Drug); Daptomycin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: St. John Health System, Michigan


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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Clinical Success at Test of Cure Visit.

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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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. 0ยบ 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

Locations and Contacts

Additional Information

Starting date: June 2011
Last updated: January 16, 2014

Page last updated: August 23, 2015

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