A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) vs 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.

Trial Profile

A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) vs 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.

Discontinued
Phase of Trial: Phase III

Latest Information Update: 01 Sep 2016

At a glance

  • Drugs Ceftaroline fosamil (Primary) ; Aztreonam; Vancomycin
  • Indications Methicillin-resistant Staphylococcus aureus infections; Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Sponsors AstraZeneca
  • Most Recent Events

    • 01 Sep 2016 Results published in the Journal of Antimicrobial Chemotherapy
    • 30 Mar 2016 Protocol amended as time frame of primary endpoint changed from 8-15 days to 7- 20 days after the last dose of study drug as reported by ClinicalTrials.gov.
    • 28 Jan 2015 Status changed from recruiting to discontinued as reported by ClinicalTrials.gov record.
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