Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections

• Clinical Cure as Measured by Comparing the Participants Signs and Symptoms at the Test of Cure (TOC) Visit to Those Recorded at Study Baseline in both the modified Intent-To-Treat and the Clinically Evaluable analysis sets [ Time Frame: 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  

• The clinical cure rate in the modified intent-to-treat and clinically evaluable analysis sets [ Time Frame: within 24 hours of completion of last infusion of study drug ] [ Designated as safety issue: No ]
  
• The per-patient microbiological favorable response in the microbiological modified intent-to-treat and microbiologically evaluable analysis sets [ Time Frame: within 24 hours of completion of the last infusion of study drug and 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  
• The clinical cure rate and per-pathogen microbiological favorable response by baseline pathogen in the microbiological modified intent-to-treat and microbiologically evaluable analysis sets [ Time Frame: 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  
• Clinical relapse in patients who were clinically cured at the test of cure visit in the clinically evaluable analysis set [ Time Frame: 21 to 35 days after the last dose of study drug ] [ Designated as safety issue: No ]
  
• Re-infection and recurrence rate in patients who were microbiological successes at the test of cure visits in the microbiologically evaluable analysis set [ Time Frame: 21 to 35 days after the last dose of study drug ] [ Designated as safety issue: No ]
  
• Super-infection rate in the microbiologically evaluable analysis set [ Time Frame: within 24 hours of completion of the last infusion of study drug ] [ Designated as safety issue: No ]
  
• New infection rate in the microbiologically evaluable analysis set [ Time Frame: 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  
• Colonization rate in patients who had a clinical assessment in the microbiologically evaluable analysis set [ Time Frame: within 24 hours of completion of the last infusion of study drug or 8 to 15 days after the last dose of study drug ] [ Designated as safety issue: No ]
  
• Early response rate in the modified intent-to-treat and clinically evaluable analysis sets [ Time Frame: at 48 to 72 hours of treatment ] [ Designated as safety issue: No ]
  
• The safety and tolerability by incidence and severity of adverse events, vital signs, clinical laboratory tests, ECGs and physical exam [ Time Frame: study duration (26 days up to 51 days) ] [ Designated as safety issue: Yes ]
  
• Description of population pharmacokinetics of ceftaroline and ceftaroline fosamil in this patient population. [ Time Frame: Within 15 minutes prior to start of infusion, 120 min +/- 5 min following start of infusion through end of infusion, 3-5 hours after start of infusion, and 6-8 hours after start of study drug and prior to next infusion ] [ Designated as safety issue: No ]
  
• PK profiles, including Cmax, Tmax, t½λz, AUC, plasma clearance, Vz, Vss, and mean residence time, of ceftaroline, ceftaroline fosamil and ceftaroline M-1 with intensive sampling in a subset of about 45 patients [ Time Frame: Within 15 minutes prior to start of infusion and following the start of infusion at 60, 90, 115, 125, 135 minutes and 2.5, 3, 4, 5, 6, and 8 hours ] [ Designated as safety issue: No ]
  

A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities