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A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections.

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Trial Profile

A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections.

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 01 Jun 2016

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At a glance

  • Drugs Ceftaroline fosamil (Primary) ; Aztreonam; Cefazolin; Vancomycin
  • Indications Bacterial skin diseases
  • Focus Adverse reactions
  • Sponsors Cerexa; Forest Laboratories

    • Most Recent Events

    • 31 May 2016 Results of Modified Intent-to-Treat (MITT) population (n=159) 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.
    • 09 May 2016 Results published in the Pediatric Infectious Disease Journal
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