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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Aztreonam; Ceftaroline fosamil; Cephalosporins; Linezolid

Criteria

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