Daptomycin Versus Vancomycin in Patients With Skin Infections Due to MRSA (DAPHEOR1006)

Inclusion Criteria:

1. ≥18 years of age

2. Primary reason for hospitalization is skin and skin structure infection of a complicated nature (e.g. 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 patient 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 three of the following clinical signs and symptoms associated with the cSSSI:

   i. Pain; tenderness to palpation; ii. Elevated Temperature [>37.5°C (99.5° F) oral or >38° C (100.2° F) rectal]; iii. Elevated White blood count (WBC) >10,000/mm3; iv. Swelling and/or induration; erythema; v. Purulent or seropurulent drainage or discharge

3. 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)
4. Informed consent obtained and signed
5. In patient hospitalization no more than 24 hours prior to randomization

Exclusion Criteria:

1. Patients with known bacteremia, osteomyelitis, septic arthritis, or endocarditis
2. Conditions where surgery (in and of itself) constitutes curative treatment of the infection (e.g., amputation, Incision &Drainage)
3. cSSSIs which can be managed with an oral antibiotic
4. Patients where hospitalization is expected to be <48hrs
5. Nosocomial infection
6. Patients with necrotizing infections or concomitant gangrene
7. 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
8. Pathogens identified at study entry to be nonsusceptible to daptomycin or vancomycin
9. Patients with neutropenia or compromised immune function [i.e., severe neutropenia (absolute neutrophil count <500 cells/μL) or is anticipated to develop severe neutropenia during the study period due to prior or planned therapy]
10. Renal insufficiency (calculated CLcr <30 mL/min or on dialysis)
11. Known to be allergic or intolerant to daptomycin or vancomycin
12. Pregnant or nursing mothers
13. Suspected implanted device or prosthetic as source of infection
14. Is considered unlikely to comply with study procedures or to be available for follow-up contact