Ceftobiprole Versus Daptomycin in <i>Staphylococcus Aureus</i> Bacteremia: A Novel Protocol for a Double-Blind, Phase III trial
Kamal Hamed, Marc Engelhardt, Mark E. Jones, Mikael Saulay, Thomas L Holland, Harald Seifert, Vance G. Fowler
Abstract
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