- First presentation of ERADICATE phase 3 study data
- Study met its primary and secondary endpoints comparing ceftobiprole versus daptomycin with or without aztreonam
IDWeek is the annual meeting of the
Positive topline results of the ERADICATE study, demonstrating non-inferiority to daptomycin, with or without aztreonam, for the primary objective, had been reported in
Dr.
Basilea is planning to submit a New Drug Application (NDA) for ceftobiprole to the
Ceftobiprole at IDWeek 2022 Late Breaking Clinical Trials | |
- | LB2302 - Ceftobiprole Compared to Daptomycin With or Without Optional Aztreonam for the Treatment of Complicated Staphylococcus aureus Bacteremia (SAB): Results of a Phase 3, Randomized, Double-Blind Trial (ERADICATE) – Thomas L. Holland, |
For further information please visit idweek.org.
About ceftobiprole
Ceftobiprole medocaril, the prodrug of the active moiety ceftobiprole, is a cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria. This includes methicillin-susceptible and resistant Staphylococcus aureus (
About the ceftobiprole phase 3 program
The ERADICATE study1 was a randomized, double-blind, multicenter phase 3 study, which enrolled 390 patients with
The second study of the program, the TARGET study4, was a randomized, double-blind, multicenter phase 3 study, which enrolled 679 patients with acute bacterial skin and skin structure infections (ABSSSI) and compared the safety and efficacy of intravenous ceftobiprole medocaril with intravenous vancomycin plus intravenous aztreonam. The study was conducted at more than 30 clinical centers in the
The two phase 3 studies were conducted under Special Protocol Assessment (SPA) agreements with the
Basilea’s ceftobiprole phase 3 program is funded in part (up to
About Staphylococcus aureus bacteremia (SAB)
Staphylococcus aureus bacteremia is a leading cause of bloodstream infections, responsible for a broad variety of complications and has been associated with significant morbidity and a mortality of 20 to 40%.5, 6 Several studies have demonstrated that MRSA bacteremia is associated with a significantly higher mortality rate compared with
About Basilea
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in
Disclaimer
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This press release can be downloaded from www.basilea.com.
References
- ERADICATE: ClinicalTrials.gov identifier NCT03138733
K. Hamed, M. Engelhardt, M. E. Jones et al. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiology. 2020 (1), 35-48 - Basilea ad hoc announcement: Basilea announces positive results of phase 3 ERADICATE study with ceftobiprole in Staphylococcus aureus bacteremia (SAB).
June 28, 2022 : https://www.basilea.com/news#news_1371 - Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed:
October 12, 2022 ] - TARGET: ClinicalTrials.gov identifier NCT03137173
J. S. Overcash, C. Kim, R. Keech R et al. Ceftobiprole Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Results of a Phase 3, Randomized, Double-blind Trial (TARGET). Clinical Infectious Diseases 2021 (73), e1507-e1517 - A. G. Jensen, C. H. Wachmann,
F. Espersen et al. Treatment and outcome of Staphylococcus aureus bacteremia: a prospective study of 278 cases. Archives of Internal Medicine 2002 (162), 25-32 - J.-
L. Wang , S.-Y. Chen , J.-T. Wang et al. Comparison of both clinical features and mortality risk associated with bacteremia due to community-acquired methicillin-resistant Staphylococcus aureus and methicillin-susceptible S. aureus. Clinical Infectious Diseases 2008 (46), 799-806 - S. I. Blot, K. H. Vandewoude, E. A. Hoste et al. Outcome and attributable mortality in critically ill patients with bacteremia involving methicillin-susceptible and methicillin-resistant Staphylococcus aureus. Archives of Internal Medicine 2002 (162), 2229-2235
- S. E. Cosgrove,
G. Sakoulas , E. N. Perencevich et al. Comparison of mortality associated with methicillin-resistant and methicillin-susceptible Staphylococcus aureus bacteremia: a meta-analysis. Clinical Infectious Diseases 2003 (36), 53-59
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- Press release (PDF)
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