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

St. John Health System, Michigan

Status and phase: Terminated; Phase 4

Conditions: Bacteremia

Treatments: Drug: Vancomycin; Drug: Daptomycin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01287832

IND 109,614 (Other Identifier)

SJ1210-01

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

High dose vancomycin

Active Comparator group

Description:

Vancomycin dosed to achieve a trough of 15-20 microgram/mL.

Treatment:

Drug: Vancomycin

High-dose daptomycin

Experimental group

Description:

Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)

Treatment:

Drug: Daptomycin