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A Randomized, Double-blind, Multicenter Study to Establish the Safety and Efficacy of Ceftobiprole Medocaril Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections

Trial Profile

A Randomized, Double-blind, Multicenter Study to Establish the Safety and Efficacy of Ceftobiprole Medocaril Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Feb 2024

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At a glance

  • Drugs Ceftobiprole medocaril (Primary) ; Aztreonam; Vancomycin
  • Indications Bacterial infections; Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms TARGET
  • Sponsors Basilea Pharmaceutica
  • Most Recent Events

    • 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.
    • 04 Aug 2023 According to a Basilea Pharmaceutica media release, company announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA). The NDA submission includes clinical efficacy and safety data from the phase 3 studies ERADICATE (SAB), TARGET (ABSSSI), and a phase 3 study in CABP.
    • 18 Apr 2023 According to a Basilea Pharmaceutica media release, company expects to submit the NDA for the three indications of Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP) in the third quarter of 2023 and it is expected that the FDA will take regulatory decision in the second quarter of 2024.
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