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

• Clinical Cure Rate at Test of Cure (MITT Population) [ Time Frame: 8-15 days after the end of treatment ] [ Designated as safety issue: No ]

  Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.

  Failure: Requirement of alternative antimicrobial therapy for primary infection of cSSSI due to inadequate response, recurrence, new infection at the same site; treatment-limiting AE; requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.

  Indeterminate: Inability to determine an outcome

• 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 ] [ Designated as safety issue: No ]

• Microbiological Success Rate at the TOC Visit [ Time Frame: 8-15 days after last dose of study drug ] [ Designated as safety issue: No ]
• Clinical Response at the End of Therapy (EOT) Visit [ Time Frame: Last day of study drug administration ] [ Designated as safety issue: No ]
• Clinical and Microbiological Response by Pathogen at the TOC Visit [ Time Frame: 8-15 days after last dose of study drug ] [ Designated as 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 ] [ Designated as safety issue: No ]
• Microbiological Reinfection or Recurrence at the LFU Visit [ Time Frame: 21 to 35 days after the last dose of study drug ] [ Designated as safety issue: No ]
• Assess Safety [ Time Frame: First dose of study drug through TOC visit ] [ Designated as safety issue: No ]
  Comparisons of the number of participants with Adverse Events

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.

• 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.
  Other Name: Active Comparator
• Drug: Ceftaroline
  600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
  Other Name: Experimental

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

• Corey GR, Wilcox MH, Talbot GH, Thye D, Friedland D, Baculik T; CANVAS 1 investigators. CANVAS 1: the first Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv41-51.
• Corey GR, Wilcox M, Talbot GH, Friedland HD, Baculik T, Witherell GW, Critchley I, Das AF, Thye D. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010 Sep 15;51(6):641-50.

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.