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 Ceftaroloine Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection (cSSSI)”

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

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.
• Drug: Placebo
  • Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Ceftaroline fosamil for Injection
  • Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
• Active Comparator: IV Vancomycin plus IV Aztreonam
  • Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.

Primary Measures

• Clinical Cure Rate at Test of Cure (TOC) (MITT Population)
  • Time Frame: 8-15 days after last dose of study drug administration
    Safety Issue?: No
• The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the CE Populations.
  • Time Frame: 8-15 days after last dose of study drug
    Safety Issue?: No

Secondary Measures

• To Evaluate the Microbiological Success Rate at the TOC Visit
  • Time Frame: 8-15 days after the last dose of study drug
    Safety Issue?: No
• To Evaluate the Clinical Response at the End of Therapy (EOT) Visit
  • Time Frame: last day of study drug administration
    Safety Issue?: No
• To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit
  • Time Frame: 8-15 days after last dose of study drug
    Safety Issue?: No
• To Evaluate Clnical Relapse at the Late Follow Up (LFU) Visit
  • Time Frame: 21 to 35 days after the last dose of study drug
    Safety Issue?: No
• To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit
  • Time Frame: 21-35 days after last dose of study drug
    Safety Issue?: Yes
• To Evaluate Safety
  • Time Frame: first study drug dose through TOC
    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 Investigator: Cerexa, Inc. Industry

Overall Clinical Trial Officials and Contacts

Mark Wilcox, MD Principal Investigator Old Medical School  

Information obtained from ClinicalTrials.gov on February 12, 2012

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