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: 27 Feb 2017

At a glance

  • Drugs Ceftobiprole medocaril (Primary) ; Ceftazidime; Vancomycin
  • Indications Gram-negative infections; Gram-positive infections; Methicillin-resistant Staphylococcus aureus infections; Pseudomonal infections; Skin and soft tissue infections; Staphylococcal infections
  • Focus Registrational; Therapeutic Use
  • Acronyms STRAUSS-II
  • Sponsors Johnson & Johnson
  • 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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