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A Multicentre, Randomized, Investigator-blind, Active-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Ceftobiprole Versus Intravenous Standard-of-care Cephalosporin Treatment With or Without Vancomycin in Paediatric Patients Aged From 3 Months to Less Than 18 Years With Hospital-acquired Pneumonia or Community-acquired Pneumonia Requiring Hospitalisation

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Trial Profile

A Multicentre, Randomized, Investigator-blind, Active-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Ceftobiprole Versus Intravenous Standard-of-care Cephalosporin Treatment With or Without Vancomycin in Paediatric Patients Aged From 3 Months to Less Than 18 Years With Hospital-acquired Pneumonia or Community-acquired Pneumonia Requiring Hospitalisation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2024

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At a glance

  • Drugs Ceftobiprole medocaril (Primary) ; Ceftazidime; Ceftriaxone; Vancomycin
  • Indications Bacterial infections; Community-acquired pneumonia; Nosocomial pneumonia
  • Focus Adverse reactions; Registrational
  • Sponsors Basilea Pharmaceutica

    • Most Recent Events

    • 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.
    • 18 Mar 2020 Status changed from active, no longer recruiting to completed.
    • 11 Mar 2020 Status changed from recruiting to active, no longer recruiting.

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