A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections

Trial Profile

A Phase III, Randomized, Double-Blind Study of Ceftobiprole Versus Comparator in the Treatment of Complicated Skin and Skin Structure Infections

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Apr 2016

At a glance

  • Drugs Ceftobiprole medocaril; Vancomycin
  • Indications Gram-positive infections; Methicillin-resistant Staphylococcus aureus infections; Skin and soft tissue infections; Staphylococcal infections
  • Focus Registrational; Therapeutic Use
  • Acronyms STRAUSS-I
  • Sponsors Basilea Pharmaceutica; Janssen Research & Development
  • Most Recent Events

    • 15 Apr 2016 According to a Basilea Pharmaceutica media release, results of pooled post hoc analysis from four phase III studies four double-blind, randomized, phase 3 studies in complicated skin or pulmonary infections were presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
    • 12 Apr 2016 Results (post-hoc pooled analysis of this and other three studies, n = 3031) assessing clinical cure and mortality presented at the 26th European Congress of Clinical Microbiology and Infectious Diseases.
    • 31 Dec 2009 The US FDA stated that the NDA could not be approved based on inadequate monitoring of the STRAUSS I and II clinical trial sites, and the high proportion of unreliable/unverifiable trial data, according to a Basilea media release.
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