drugset / Trial / NCT03138733
Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
Phase 3
Completed
390 enrolled
Basilea Pharmaceutica
Department of Health and Human Services · collab
RandomizedParallel-groupQuadruple-blindTreatment
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
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 medocaril | 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 | — | — |