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)

• Status: Completed
• Trial end date: 2016-04-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Linezolid; Oxazolidinones; Tedizolid; Torezolid; Torezolid phosphate

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