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)
Condition: Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Intervention: Tedizolid (BAY119-2631); Placebo Tedizolid (BAY119-2631); Linezolid; Placebo Linezolid
Intervention description: 50 % of the participants will be randomized to this arm and will receive 200 mg Tedizolid once daily i.v to oral from 1-6 days; 50 % of the participants will be randomized to this arm and will receive 200 mg Placebo Tedizolid once daily i.v to oral from 7-10 days; 50 % of the participants will be randomized to this arm and will receive 600 mg Linezolid twice daily i.v. to oral from 1-10 days; 50 % of the participants will be randomized to this arm and will receive 600 mg Placebo Linezolid twice daily i.v. to oral from 1-10 days
Intervention MeSH terms: Linezolid; Tedizolid; Oxazolidinones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 598.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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