The following is a summary of “Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia,” published in the September 2023 issue of Infectious Disease by Holland, et al.
Researchers started a retrospective study to investigate the effectiveness of ceftobiprole for complicated Staphylococcus aureus bacteremia, including methicillin-resistant S. aureus.
They conducted a phase 3 double-blind, double-dummy, noninferiority trial where adults with complicated S. aureus bacteremia were randomly allocated in a 1:1 ratio. Patients were administered ceftobiprole (500 mg) intravenously 6 hours for 8 days and every 8 hours afterward or daptomycin (6 to 10 mg per kilogram) of body weight (24 hours), with optional aztreonam as per the trial-site investigators’ decision. The main outcome, overall treatment success 70 days after randomization, was assessed by a data review committee with a noninferiority margin of 15%. The committee members needed to be made aware of the trial-group assignments. Safety was also evaluated.
The results showed 390 patients with 387 (189 in the ceftobiprole group and 198 in the daptomycin group) were confirmed to have S. aureus bacteremia and received ceftobiprole or daptomycin (modified intention-to-treat population). Overall treatment success was observed in 132 of 189 patients (69.8%) in the ceftobiprole group and 136 of 198 patients (68.7%) in the daptomycin group (adjusted difference, 2.0 percentage points; 95% CI, −7.1 to 11.1). Similar findings were noted between the ceftobiprole and daptomycin groups in key subgroups and regarding secondary outcomes, including mortality (9.0% and 9.1%, respectively; 95% CI, −6.2 to 5.2) and the percentage of patients with microbiologic eradication (82.0% and 77.3%; 95% CI, −2.9 to 13.0). Adverse events were reported in 121 of 191 patients (63.4%) who received ceftobiprole, 117 of 198 patients (59.1%) who received daptomycin, with serious adverse events reported in 36 patients (18.8%), and 45 patients (22.7%). Gastrointestinal adverse events, primarily mild nausea, occurred more frequently with ceftobiprole.
They concluded that ceftobiprole is as effective as daptomycin for treating complicated Staphylococcus aureus bacteremia.