Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas

same as above

Inclusion criteria

• Read and sign the informed consent form after the nature of the study has been fully explained;
• Male or female > or = 18 years of age;
• If female of childbearing potential, a negative pregnancy test is required;
• Primary diagnosis of cellulitis/ erysipelas

• with onset of signs or symptoms within 3 days of 1st dose of study medication
• requiring hospitalization, and severe enough to warrant IV antibiotics
• temperature >37.5°C (99.5° F) oral or >38° C (100.2° F) rectal, documented within 48 hours prior to enrollment, and
• anticipated treatment to be limited to medical (NOT surgical) interventions
• at an anatomical location that allows of a clear assessment of the erythema margin

Exclusion criteria

• Pregnant or lactating female;
• Conditions where required surgery (in and of itself) constitutes curative treatment of the infection or removal of infected site (e.g., amputation);
• Conditions requiring emergent surgical intervention at the site of infection (e.g., progressive necrotizing infections);
• Previous systemic antimicrobial therapy exceeding 24 hours duration, administered anytime during the 72 hours prior to the first dose of study drug unless on previous antibiotics for at least 72 hours and without any clinical improvement;
• Cellulitis associated with a wound infection or ulcer requiring incision and drainage or debridement
• Perirectal abscess or hidradenitis suppurativa or third degree burn infections
• Buccal cellulitis, facial cellulitis, perianal cellulitis, or periorbital cellulitis;
• Known or suspected osteomyelitis, pneumonia, bacteremia, endocarditis, or urinary tract infection;
• Known to be allergic or intolerant to study medications;
• Subjects with a Creatinine Clearance (CLCR) <30 mL/min;
• Requirement for non-study systemic antibiotics;
• Requirement for systemic steroids from enrollment through stabilization of cellulitis;
• Rhabdomyolysis;
• Neutropenic subjects with absolute neutrophil count ≤ 500 cells/mm3