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

NCT ID: NCT01287832

Last Updated: 2014-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-01-31

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.

Conditions

Bacteremia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High dose vancomycin

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

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

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

High-dose daptomycin

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

Group Type: EXPERIMENTAL

Daptomycin

Intervention Type: DRUG

Interventions

Vancomycin

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

Intervention Type: DRUG

Daptomycin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: collaborator

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: collaborator

St. John Health System, Michigan

OTHER

Sponsor Role: lead

Responsible Party

Leonard B. Johnson

Division Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IND 109,614

Identifier Type: OTHER

Identifier Source: secondary_id

SJ1210-01

Identifier Type: -

Identifier Source: org_study_id