Ceftobiprole and the kidney: secondary analyses of the ERADICATE Staphylococcus aureus bacteraemia trial
Objectives Ceftobiprole demonstrated noninferiority to daptomycin for the treatment of Staphylococcus aureus bacteraemia. A range of post hoc exploratory analyses were undertaken to better inform additional key clinical questions—including how ceftobiprole efficacy interacts with underlying renal dysfunction and whether it is associated with any risk of nephrotoxicity. Methods We used data from ERADICATE, a phase 3 double-blind randomized controlled trial comparing ceftobiprole against daptomycin for the treatment of S. aureus bacteraemia, to report clinical outcomes stratified by renal function and rates of renal injury or change in creatinine clearance during treatment. Results Among patients with creatinine clearance <50 mL/minute, 22 of 41 (54%) in the ceftobiprole group and 20 of 39 (51%) in the daptomycin group achieved clinical success. The proportion of patients experiencing renal injury or failure on treatment were similar between ceftobiprole (10/166, 5.5%) and daptomycin (7/170, 4.1%); no significant change in renal function was noted overall or between treatment groups. Conclusions Ceftobiprole exhibited similar rates of clinical success regardless of baseline renal dysfunction and showed no association with renal injury or change in creatinine clearance relative to daptomycin. (Funded by Basilea Pharmaceutica International and the U.S. Department of Health and Human Services; ERADICATE ClinicalTrials.gov number, NCT03138733.)
