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A Randomized, Double-blind, Multi-center Study to Establish the Efficacy and Safety of Ceftobiprole Medocaril Compared to Daptomycin in the Treatment of Staphylococcus Aureus Bacteremia, Including Infective Endocarditis

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Trial Profile

A Randomized, Double-blind, Multi-center Study to Establish the Efficacy and Safety of Ceftobiprole Medocaril Compared to Daptomycin in the Treatment of Staphylococcus Aureus Bacteremia, Including Infective Endocarditis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 May 2024

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At a glance

  • Drugs Ceftobiprole medocaril (Primary) ; Aztreonam; Daptomycin
  • Indications Abscess; Bacteraemia; Bacterial endocarditis; Endocarditis; Infectious arthritis; Osteomyelitis; Skin infections; Soft tissue infections; Staphylococcal infections; Thrombophlebitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ERADICATE
  • Sponsors Basilea Pharmaceutica

Most Recent Events

  • 03 May 2024 According to a Basilea Pharmaceutica media release, the new data from this trial have been presented at ESCMID Global 2024, the annual meeting of the European Society of Clinical Microbiology and Infectious Diseases, in Barcelona, Spain.
  • 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).
  • 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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