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: 04 Oct 2023
Price :
$35
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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
- 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.
- 03 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.
- 15 Apr 2016 According to a Basilea Pharmaceutica media release, results of pooled post hoc analysis from four phase III studies four double-blind, randomized, phase 3 studies in complicated skin or pulmonary infections were presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).