A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospitalization

Trial Profile

A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospitalization

Completed
Phase of Trial: Phase II/III

Latest Information Update: 31 May 2016

At a glance

  • Drugs Ceftaroline fosamil (Primary) ; Amoxicillin/clavulanic acid; Ceftriaxone
  • Indications Bacterial infections; Community-acquired pneumonia
  • Focus Adverse reactions; Registrational
  • Sponsors Forest Laboratories
  • Most Recent Events

    • 31 May 2016 Results published in Allergan media release.
    • 31 May 2016 According to Allergan media release, the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for TEFLARO (ceftaroline fosamil), new indications for pediatric patients 2 months of age to less than 18 years of age with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae and other designated susceptible bacteria.
    • 18 Apr 2016 Results published in the Pediatric Infectious Disease Journal
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