A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects With Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus Aureus

Trial Profile

A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects With Community-acquired Bacterial Pneumonia at Risk for Infection Due to Methicillin-resistant Staphylococcus Aureus

Completed
Phase of Trial: Phase IV

Latest Information Update: 16 Feb 2016

At a glance

  • Drugs Ceftaroline fosamil (Primary) ; Ceftriaxone; Vancomycin
  • Indications Community-acquired pneumonia; Methicillin-resistant Staphylococcus aureus infections
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Cerexa
  • Most Recent Events

    • 16 Feb 2016 According to Allergan media release, the U.S. Food and Drug Administration (FDA) has accepted for filing the company's supplemental New Drug Application (sNDA) for TEFLARO (ceftaroline fosamil).
    • 15 Apr 2014 According to the ClinicalTrials.gov record, status changed from active, no longer recruiting to completed.
    • 09 Dec 2013 Planned end date changed from 1 Mar 2017 to 1 Mar 2014 as reported by ClinicalTrials.gov record.
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