Overview

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