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)

A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate and Intravenous to Oral 10-Day Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all subjects.

Number of participants with adverse evnets as a measure of safety and tolerability will be covered in Adverse Events section.

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