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A phase III, randomized, double-blind study of ceftobiprole versus comparator in the treatment of complicated skin and skin structure infections

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Trial Profile

A phase III, randomized, double-blind study of ceftobiprole versus comparator in the treatment of complicated skin and skin structure infections

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Dec 2021

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At a glance

  • Drugs Ceftobiprole medocaril (Primary) ; Ceftazidime; Vancomycin
  • Indications Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms STRAUSS-II
  • Sponsors Janssen Research & Development; Johnson & Johnson
  • Most Recent Events

    • 16 May 2018 Results assessing PK and Target Attainment of Ceftobiprole in Asian and Non-Asian Subjects using data from this and one another PK study, published in the Clinical Pharmacology in Drug Development
    • 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.

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