Clinical trial NCT02066402 (phase 3, status: completed)
Conditions: bacterial infections
ICD codes: A49.9, A04.9, A04.8, A49.8
Drugs: tedizolid (bay119-2631), placebo tedizolid (bay119-2631), linezolid, placebo linezolid
SMILES: CN1N=NC(=N1)C1=CC=C(C=N1)C1=CC=C(C=C1F)N1C[C@H](COP(O)(O)=O)OC1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC(=O)NC[C@H]1CN(C(=O)O1)C1=CC(F)=C(C=C1)N1CCOCC1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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