Ceftobiprole noninferior for overall treatment success; findings consistent in key subgroups and for secondary outcomes
By Elana Gotkine HealthDay Reporter
WEDNESDAY, Oct. 4, 2023 (HealthDay News) — For patients with complicated Staphylococcus aureus bacteremia, ceftobiprole is noninferior to daptomycin for overall treatment success, according to a study published online Sept. 27 in the New England Journal of Medicine.
Thomas L. Holland, M.D., from Duke University in Durham, North Carolina, and colleagues conducted a phase 3 noninferiority trial involving adults with complicated S. aureus bacteremia who were randomly assigned to receive ceftobiprole or daptomycin plus optional aztreonam at the discretion of the investigators (189 and 198 patients, respectively). The primary outcome was overall treatment success 70 days after randomization, with a noninferiority margin of 15 percent.
The researchers found that 69.8 and 68.7 percent of the patients in the ceftobiprole and daptomycin groups, respectively, had overall treatment success (adjusted difference, 2.0 percentage points; 95 percent confidence interval, −7.1 to 11.1). In key subgroups and with respect to secondary outcomes, including mortality and the percentage of patients with microbiologic eradication, the findings were consistent between the groups. Adverse events were reported in 63.4 and 59.1 percent of patients receiving ceftobiprole and daptomycin, respectively; serious adverse events were reported in 18.8 and 22.7 percent.
“In addition, microbiologic eradication, relapse of bacteremia, and new or worsening S. aureus bacteremia complications were similar in the two trial groups, findings that further indicate that ceftobiprole was not less effective than daptomycin,” the authors write.
Several authors disclosed ties to biopharmaceutical companies, including Basilea Pharmaceutica International, which markets ceftobiprole and partially funded the study.
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