Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

Official Title: “A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline 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.

Additional purpose of the 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: IV Vancomycin plus IV 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.
• Drug: Ceftaroline
  • 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Ceftaroline for Injection
• Active Comparator: IV Vancomycin and IV Aztreonam

Primary Measures

• Clinical Cure Rate at Test of Cure (MITT Population)
  • Time Frame: 8-15 days after the end of treatment
    Safety Issue?: No
• Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population
  • Time Frame: 8-15 days after last dose of study drug
    Safety Issue?: No

Secondary Measures

• Microbiological Success Rate at the TOC Visit
  • Time Frame: 8-15 days after last dose of study drug
    Safety Issue?: No
• Clinical Response at the End of Therapy (EOT) Visit
  • Time Frame: Last day of study drug administration
    Safety Issue?: No
• Clinical and Microbiological Response by Pathogen at the TOC Visit
  • Time Frame: 8-15 days after last dose of study drug
    Safety Issue?: No
• Clinical Relapse at the Late Follow Up (LFU) Visit
  • Time Frame: 21 to 35 days after the last dose of study drug
    Safety Issue?: No
• Microbiological Reinfection or Recurrence at the LFU Visit
  • Time Frame: 21 to 35 days after the last dose of study drug
    Safety Issue?: No
• Assess Safety
  • Time Frame: First dose of study drug through TOC visit
    Safety Issue?: No

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 Investigator: Cerexa, Inc. Industry

Overall Clinical Trial Officials and Contacts

Ralph Corey, MD Principal Investigator Duke University  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00424190

Study ID Number: P903-06

ClinicalTrials.gov Identifier: NCT00424190

Health Authority: United States: Food and Drug Administration