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

Completed · Phase 2

Conditions studied: Bacterial Infection

In brief

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.

Key facts

Study ID

NCT00633152

Run by

Forest Laboratories

People needed

150

Starts

2008-02-01

Expected to finish

2008-07-01

Last updated by the study team

2017-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Investigational Site — Buena Park, California, United States
• Investigational Site — Long Beach, California, United States
• Investigational Site — Los Angeles, California, United States
• Investigational Site — Rolling Hills Estate, California, United States
• Investigational Site — San Diego, California, United States
• Investigational Site — Atlantis, Florida, United States
• Investigational Site — Columbus, Georgia, United States
• Investigational Site — Savannah, Georgia, United States
• Investigational Site — Minneapolis, Minnesota, United States
• Investigational Site — Butte, Montana, United States
• Investigational Site — Somers Point, New Jersey, United States
• Investigational Site — Columbus, Ohio, United States
• Investigational Site — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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