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Randomized, Double-Blind, Multicenter Study of Ceftobiprole Medocaril Versus Ceftriaxone with/without Linezolid in Treatment of Subjects Hospitalized With Community-Acquired Pneumonia

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Trial Profile

Randomized, Double-Blind, Multicenter Study of Ceftobiprole Medocaril Versus Ceftriaxone with/without Linezolid in Treatment of Subjects Hospitalized With Community-Acquired Pneumonia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jan 2025

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At a glance

  • Drugs Ceftobiprole medocaril (Primary) ; Ceftriaxone; Linezolid
  • Indications Bacterial infections; Community-acquired pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms CAP
  • Sponsors Basilea Pharmaceutica

Most Recent Events

  • 04 Apr 2024 According to a Basilea Pharmaceutica media release, the US FDA approved ZEVTERA (ceftobiprole medocaril sodium for injection), for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).
  • 03 Apr 2024 According to FDA media release, approval of Zevtera in pediatric patients three months to less than 18 years with CABP was supported by evidence from the CABP trial of Zevtera in adults and a trial in 138 pediatric subjects three months to less than 18 years of age with pneumonia.
  • 02 Oct 2023 According to a Basilea Pharmaceutica media release,company announced that the US FDA has accepted filing of the NDA for ceftobiprole supported by clinical efficacy and safety data from the phase 3 studies ERADICATE, TARGET &CABP.3 seeking approval for treating patients in Staphylococcus aureus bacteremia,right-sided infective endocarditis,acute bacterial skin and skin structure infections &community-acquired bacterial pneumonia. The FDA has set April 03, 2024, as PDUFA goal date.

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