Official Title: “A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroloine Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection”

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

Additonal purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Intervention(s) in this Clinical Trial

• Drug: ceftaroline
  • 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
• Drug: vancomycin plus aztreonam
  • vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B

Primary Measures

• Cure rate of ceftaroline treatment compared with that of vancomycin plus aztreonam
  • Time Frame: Test-of-Cure visit
    Safety Issue?: No

Secondary Measures

• Evaluate the microbiological success rate
  • Time Frame: Test-of-Cure visit
    Safety Issue?: No
• Evaluate the clinical response
  • Time Frame: End-of-Therapy visit
    Safety Issue?: No
• Evaluate the clinical and microbiological response by pathogen
  • Time Frame: Test-of-Cure visit
    Safety Issue?: No
• Evaluate clinical relapse
  • Time Frame: Late Follow-up visit
    Safety Issue?: No
• Evaluate microbiological reinfection or recurrence
  • Time Frame: Late Follow-up visit
    Safety Issue?: No
• Evaluate safety
  • Time Frame: Throughout the dosing period and up to the TOC visit
    Safety Issue?: Yes

Inclusion Criteria:

• Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.

Exclusion Criteria:

• Prior treatment of current cSSSI with an antimicrobial.
• Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.

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

Mark Wilcox, MD Principal Investigator Old Medical School  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00423657

Study ID Number: P903-07

ClinicalTrials.gov Identifier: NCT00423657

Health Authority: United States: Food and Drug Administration