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: 11 Mar 2024
Price :
$35
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At a glance
- Drugs Ceftobiprole medocaril (Primary) ; Aztreonam; Daptomycin
- Indications Abscess; Bacteraemia; Bacterial endocarditis; Staphylococcal infections
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms ERADICATE
- Sponsors Basilea Pharmaceutica
- 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.
- 28 Sep 2023 According to a Basilea Pharmaceutica media release, data from this study were published in the New England Journal of Medicine (NEJM),
- 28 Sep 2023 Results published in the Basilea Pharmaceutica Media Release