Overview
Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA
Status:
Completed
Completed
Trial end date:
2012-10-05
2012-10-05
Target enrollment:
0
0
Participant gender:
All
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 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Cubist Pharmaceuticals LLCTreatments:
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