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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

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.

Intervention(s) in this Clinical Trial

• Drug: ceftaroline
  • 600 mg injected every 12 hours for at least 5 but not more than 14 days
• Drug: linezolid
  • 600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days (with or without aztreonam)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • ceftaroline
• Active Comparator: B
  • linezolid

Primary Measures

• Evaluate the clinical response of ceftaroline versus linezolid
  • Time Frame: Test-of-cure (TOC) visit
    Safety Issue?: No

Secondary Measures

• Evaluate the clinical response
  • Time Frame: TOC visit
    Safety Issue?: No
• Evaluate the clinical response
  • Time Frame: End-of-therapy (EOT) visit
    Safety Issue?: No
• Evaluate the microbiological response
  • Time Frame: TOC visit
    Safety Issue?: No
• Evaluate the clinical response by pathogen
  • Time Frame: TOC visit
    Safety Issue?: No
• Evaluate clinical relapse
  • Time Frame: Late Follow-up (LFU) assessment
    Safety Issue?: No
• Evaluate the microbiological reinfection or recurrence
  • Time Frame: LFU visit
    Safety Issue?: No
• Evaluate safety
  • Time Frame: adverse events (AEs) monitoring throughout the dosing period and up through the TOC visit; serious adverse events (SAEs) are to be recorded through the LFU visit or 30 days after the last dose of study drug
    Safety Issue?: Yes
• Pharmacokinetics
  • Time Frame: during study drug administration
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cerexa, Inc.

Overall Clinical Trial Officials and Contacts

Medical Monitor Cerexa Study Director Cerexa, Inc.  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00633152

Study ID Number: P903-19

ClinicalTrials.gov Identifier: NCT00633152

Health Authority: United States: Food and Drug Administration