Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

ABSSSI Efficacy Safety Tedizolid Phosphate Linezolid

Inclusion Criteria:

- Males or females >/=18 years old

- Adequate venous access for a minimum of 2 I.V. doses of study drug

- Acute Bacterial Skin and skin structure infection (ABSSSI) meeting at least 1 of the
clinical syndrome definitions listed below and requiring I.V. antibiotic therapy.
Local symptoms must have started within 7 days before the Screening Visit

- Cellulitis/erysipelas

- Major cutaneous abscess

- Wound Infection

- Suspected or documented gram-positive infection from baseline Gram stain or culture.

Exclusion Criteria:

- Uncomplicated skin and skin structure infections such as furuncles, minor abscesses

- Infections associated with, or in close proximity to, a prosthetic device

- Severe sepsis or septic shock

- Known bacteremia at time of screening

- ABSSSI due to or associated with any of the following:

- Suspected or documented gram-negative pathogens in patients with
cellulitis/erysipelas or major cutaneous abscess that require an antibiotic with
specific gram-negative coverage. Patients with wound infections where
gram-negative adjunctive therapy is warranted may be enrolled if they meet the
other eligibility criteria

- Diabetic foot infections, gangrene, or perianal abscess

- Concomitant infection at another site not including a secondary ABSSSI lesion
(eg, septic arthritis, endocarditis, osteomyelitis)

- Infected burns

- Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular
disease (arterial or venous)

- Any evolving necrotizing process (ie, necrotizing fasciitis)

- Use of antibiotics as follows:

- Systemic antibiotic with gram-positive cocci activity for the treatment of any
infection within 24 hours before the first infusion of study drug

- Patients who failed prior therapy for the primary infection site are also
excluded from enrollment

- Topical antibiotic on the primary lesion within 24 hours before the first
infusion of study drug except for antibiotic/antiseptic-coated dressing applied
to the clean postsurgical wound

- Administration of Linezolid within 30 days before the first infusion of the study
drug

- Recent history of opportunistic infections where the underlying cause of these
infections is still active (eg, leukemia, transplant, acquired immunodeficiency
syndrome [AIDS])

- Previous exposure to Tedizolid Phosphate treatment