Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA

• Status: Completed
• Trial end date: 2012-10-05
• Target enrollment: 0
• Participant gender: All

Summary

This was a real-world, prospective, open-label, multicenter study in which participants were randomized (1:1) to receive intravenous (IV) vancomycin or IV daptomycin. The purpose of this study is to compare infection-related hospital length of stay, along with a number of participant-reported outcomes, between participants with complicated skin and soft tissue infection treated with daptomycin and vancomycin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Treatments: Anti-Bacterial Agents; Daptomycin; Methicillin; Vancomycin

Criteria

Inclusion Criteria:

• ≥18 years of age

• Primary reason for hospitalization is skin and skin structure infection of a complicated nature (for example, cellulitis/erysipelas, major cutaneous abscess, or wound infection) that requires IV antibiotic treatment for an anticipated 3 to14 days and hospitalization for management

1. Further defined as infections either involving deeper soft tissue or requiring significant surgical intervention or infections in which the participant has a significant underlying disease state that complicates the response to treatment

2. Are suspected or documented to be caused by MRSA

3. At least 3 of the following clinical signs and symptoms associated with the cSSSI:

i. Pain; tenderness to palpation; ii. Elevated temperature (>37.5°Celsius [99.5° Farenheit] oral or >38° Celsius [100.2° Farenheit] rectal); iii. Elevated white blood count (WBC) >10,000/millimeters cubed (mm^3); iv. Swelling and/or induration; erythema; v. Purulent or seropurulent drainage or discharge

• Physician determination that vancomycin or daptomycin would be the initial treatment of choice for the cSSSI under study (or meets institutional criteria for use of vancomycin or daptomycin)

• Informed consent obtained and signed

• Less than 24 hours post hospital admission

Exclusion Criteria:

• Participants with known bacteremia, osteomyelitis, septic arthritis, or endocarditis

• Conditions where surgery (in and of itself) constitutes curative treatment of the infection (for example, amputation, incision and drainage)

• cSSSIs which can be managed with an oral antibiotic

• Participants where hospitalization is expected to be <48 hours

• Nosocomial infection

• Participants with necrotizing infections or concomitant gangrene

• Use of systemic antibacterial therapy for the infection for > 24 hours within 48 hours prior to the start of study drug unless (a) the infecting Gram-positive pathogen was resistant in vitro to the therapy or (b) the therapy was administered for 3 or more days with either worsening or no improvement in the infection

• Pathogens identified at study entry to be nonsusceptible to daptomycin or vancomycin

• Participants with neutropenia or compromised immune function (that is, severe neutropenia [absolute neutrophil count <500 cells per microliter (μL)] or is anticipated to develop severe neutropenia during the study period due to prior or planned therapy)

• Renal insufficiency (calculated creatinine clearance [CLcr] <30 milliliters per minute or on dialysis)

• Known to be allergic or intolerant to daptomycin or vancomycin

• Pregnant or nursing mothers

• Suspected implanted device or prosthetic as source of infection

• Is considered unlikely to comply with study procedures or to be available for follow-up contact