Intervention: Daptomycin
Trial phase: Phase 4
ATC code: J01XX09
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Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 118
Group description: Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
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

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
Are suspected or documented to be caused by MRSA
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