Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections

A Phase 2, Multicenter, Randomized, Open-label, Comparative Study to Evaluate the Efficacy and Safety of Intramuscular Ceftaroline Versus Intravenous Linezolid in Adult Subjects With Complicated Skin and Skin Structure Infections

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. The primary focus is bacterial infection.

Inclusion Criteria:

• Complicated skin and skin structure infection (cSSSI)
• Require initial hospitalization, or treatment in an emergency room or urgent care setting

Exclusion Criteria:

• Hypersensitivity or allergic reaction to any ß-lactam, ceftaroline, linezolid, aztreonam, or to their components
• Concomitant use of adrenergic or serotonergic agent
• Uncomplicated skin and skin structure infection
• Concomitant therapy with any drug known to exhibit a contraindicated drug-drug interaction
• More than 24 hours of treatment with an antimicrobial within 96 hours before randomization
• Known or suspected endocarditis, osteomyelitis, or septic arthritis
• Severely impaired renal function
• Evidence of significant hepatic, hematologic, or immunologic disease