Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA
Condition: Staphylococcal Skin Infections
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections
Intervention: Daptomycin; Vancomycin
Intervention MeSH terms: Vancomycin; Daptomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Complicated Skin and Skin Structure Infections (cSSSI); Methicillin-resistant Staphylococcus aureus (MRSA); Daptomycin; Vancomycin; Antibiotics

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.
    

Eligibility 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