The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
802
IV ceftaroline 600mg every 8 hours
IV vancomycin 15mg/kg every 12 hours
IV aztreonam 1 g every 8 hours
Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
Time frame: 7 to 20 days after the last dose of study drug
Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
Time frame: 7 to 20 days after the last dose of study drug
Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set
Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
Time frame: 7 to 20 days after the last dose of study drug
Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set
Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
Time frame: 7 to 20 days after the last dose of study drug
Clinical Response at End of Treatment (EOT) in MITT Analysis Set
The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.
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Research Site
Chula Vista, California, United States
Research Site
Orlando, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Carmel, Indiana, United States
Research Site
Hazard, Kentucky, United States
Research Site
Springfield, Massachusetts, United States
Research Site
Detroit, Michigan, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Garden City, New York, United States
Research Site
Bellaire, Texas, United States
...and 81 more locations
Time frame: On day of last dose of study drug (or + 1 day)
Clinical Response at EOT in CE Analysis Set
The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.
Time frame: On day of last dose of study drug (or +1 day)
Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC
The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC.
Time frame: 21 to 42 days after the last dose of study drug
Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set
The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline.
Time frame: 48 to 72 hours after first dose of study drug
Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME
Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set
Time frame: 7 to 20 days after the last dose of study drug