Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
Information source: Cerexa, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Infection
Intervention: ceftaroline (Drug); linezolid (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Cerexa, Inc. Official(s) and/or principal investigator(s):
Medical Monitor Cerexa, Study Director, Affiliation: Cerexa, Inc.
Overall contact:
Trial Information, Email: clinicaltrials@cerexa.com
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.
Clinical Details
Official title: A Phase 2, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Intramuscular Ceftaroline Versus Intravenous Linezolid in Adult Subjects With Complicated Skin and Skin Structure Infections
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Evaluate the clinical response of ceftaroline versus linezolid
Secondary outcome: Evaluate the clinical responseEvaluate the clinical response Evaluate the microbiological response Evaluate the clinical response by pathogen Evaluate clinical relapse Evaluate the microbiological reinfection or recurrence Evaluate safety Pharmacokinetics
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Trial Information, Email: clinicaltrials@cerexa.com
Investigational Site, Los Angeles, California 90015, United States; Recruiting
Investigational Site, San Diego, California 92114, United States; Recruiting
Investigational Site, Rolling Hills Estate, California 90274, United States; Recruiting
Investigational Site, Buena Park, California 96020, United States; Recruiting
Investigational Site, Atlantis, Florida 33462, United States; Recruiting
Investigational Site, Columbus, Georgia 31904, United States; Recruiting
Investigational Site, Savannah, Georgia 31405, United States; Recruiting
Investigational Site, Butte, Montana 59701, United States; Recruiting
Additional Information
Starting date: February 2008
Last updated: April 23, 2008
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