Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

Summary

The purpose of this study was to compare the efficacy and safety of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated Staphylococcus aureus bacteremia (SAB).

Timeline

Start

2018-08-26

Primary completion

2022-03-11

Completion

2022-03-11

Outcome

Met primary endpoint

paper Ceftobiprole was noninferior to daptomycin with respect to overall treatment success in patients with complicated S. aureus bacteremia. PMID 37754204 ↗

release “Ceftobiprole met the pre-specified efficacy objective of overall success in the modified intent-to-treat (mITT) population” basilea.com ↗

release “First double-blind registrational phase 3 study in Staphylococcus aureus bacteremia Ceftobiprole non-inferior to daptomycin, meeting primary endpoint and demonstrating similar secondary efficacy outcomes” basilea.com ↗

Publications

• Background Hamed K, Engelhardt M, Jones ME, Saulay M, Holland TL, Seifert H, Fowler VG Jr. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiol. 2020 Jan;15(1):35-48. doi: 10.2217/fmb-2019-0332. Epub 2020 Jan 10.
• Results Holland TL, Cosgrove SE, Doernberg SB, Jenkins TC, Turner NA, Boucher HW, Pavlov O, Titov I, Kosulnykov S, Atanasov B, Poromanski I, Makhviladze M, Anderzhanova A, Stryjewski ME, Assadi Gehr M, Engelhardt M, Hamed K, Ionescu D, Jones M, Saulay M, Smart J, Seifert H, Fowler VG Jr; ERADICATE Study Group. Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia. N Engl J Med. 2023 Oct 12;389(15):1390-1401. doi: 10.1056/NEJMoa2300220. Epub 2023 Sep 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftobiprole	Small molecule	500 mg	Intravenous
Comparator	Daptomycin	Other / unclassified	6 mg/kg	Intravenous
Comparator	Daptomycin	Other / unclassified	10 mg/kg	Intravenous
Comparator	Aztreonam	Small molecule	—	—

Indications