Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial.

Journal Article (Journal Article)

Although Staphylococcus aureus is a common cause of bacteremia, treatment options are limited. The need for new therapies is particularly urgent for methicillin-resistant S. aureus bacteremia (SAB). Ceftobiprole is an advanced-generation, broad-spectrum cephalosporin with activity against both methicillin-susceptible and -resistant S. aureus. This is a Phase III, randomized, double-blind, active-controlled, parallel-group, multicenter, two-part study to establish the efficacy and safety of ceftobiprole compared with daptomycin in the treatment of SAB, including infective endocarditis. Anticipated enrollment is 390 hospitalized adult patients, aged ≥18 years, with confirmed or suspected complicated SAB. The primary end point is overall success rate. Target completion of the study is in the second half of 2021. Clinicaltrials.gov identifier: NCT03138733.

Full Text

Duke Authors

Cited Authors

  • Hamed, K; Engelhardt, M; Jones, ME; Saulay, M; Holland, TL; Seifert, H; Fowler, VG

Published Date

  • January 2020

Published In

Volume / Issue

  • 15 /

Start / End Page

  • 35 - 48

PubMed ID

  • 31918579

Pubmed Central ID

  • PMC7046132

Electronic International Standard Serial Number (EISSN)

  • 1746-0921

Digital Object Identifier (DOI)

  • 10.2217/fmb-2019-0332

Language

  • eng

Conference Location

  • England