Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
NCT ID: NCT00633152
Last Updated: 2017-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2008-02-29
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ceftaroline
Intramuscular every 12 hours
ceftaroline
600 mg injected every 12 hours for at least 5 but not more than 14 days
linezolid plus optional aztreonam
Intravenous every 12 hours
linezolid
600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days
Aztreonam
1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated.
Interventions
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ceftaroline
600 mg injected every 12 hours for at least 5 but not more than 14 days
linezolid
600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days
Aztreonam
1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Require initial hospitalization, or treatment in an emergency room or urgent care setting
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor Cerexa
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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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
Countries
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Other Identifiers
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P903-19
Identifier Type: -
Identifier Source: org_study_id
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