Status:
COMPLETED
Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
Lead Sponsor:
Forest Laboratories
Conditions:
Bacterial Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
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 infecti...
Eligibility Criteria
Inclusion
- Complicated skin and skin structure infection (cSSSI)
- Require initial hospitalization, or treatment in an emergency room or urgent care setting
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00633152
Start Date
February 1 2008
End Date
July 1 2008
Last Update
March 14 2017
Active Locations (13)
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1
Investigational Site
Buena Park, California, United States, 96020
2
Investigational Site
Long Beach, California, United States, 90813
3
Investigational Site
Los Angeles, California, United States, 90015
4
Investigational Site
Rolling Hills Estate, California, United States, 90274