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

Bacteremia Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01287832
• Other study ID #: SJ1210-01
• Secondary ID: IND 109,614
• Status: Terminated
• Phase: Phase 4
• First received: January 31, 2011
• Last updated: January 16, 2014
• Start date: June 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2014
• Source: St. John Health System, Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bacteremia

Intervention

Drug:
• Vancomycin
Vancomycin dosed to achieve a trough of 15-20 microgram/mL.
• Daptomycin

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
St. John Health System, Michigan	Cubist Pharmaceuticals LLC, Henry Ford Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical Success at Test of Cure Visit.	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.	30-42 days post-treatment	Yes
Secondary	Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity		30-42 days post-treatment	Yes