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Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia
Thomas L Holland1, Sara E Cosgrove1, Sarah B Doernberg1
1From the Division of Infectious Diseases, Duke University (T.L.H., N.A.T., V.G.F.), and Duke Clinical Research Institute (T.L.H., V.G.F.) - both in Durham, NC; the Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (S.E.C.); the Division of Infectious Diseases, Department of Medicine, University of California, San Francisco, San Francisco (S.B.D.); the Division of Infectious Diseases, Department of Medicine, Denver Health, Denver (T.C.J.); Tufts Medicine and Tufts University School of Medicine, Boston (H.W.B.); Zaycev V.T. Institute of General and Emergency Surgery of the National Academy of Medical Sciences of Ukraine, Kharkiv (O.P.), Regional Clinical Hospital, Ivano-Frankivsk Regional Council, Ivano-Frankivsk (I.T.), and Dnipropetrovsk I.I. Mechnikov Regional Clinical Hospital, Dnipro (S.K.) - all in Ukraine; Eurohospital Plovdiv, Plovdiv (B.A.), and University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov," Clinic of Purulent-Septic Surgery, Sofia (I.P.) - both in Bulgaria; LTD Academician Vakhtang Bochorishvili Clinic, Tbilisi, Georgia (M.M.); N.I. Pirogov City Clinical Hospital No. 1, Moscow (A.A.); the Department of Medicine and Division of Infectious Diseases, Centro de Educación Médica e Investigaciones Clínicas, Buenos Aires (M.E.S.); Basilea Pharmaceutica International, Allschwil, Switzerland (M.A.G., M.E., K.H., D.I., M.J., M.S., J.S.); and the Institute for Medical Microbiology, Immunology, and Hygiene, Medical Faculty and University Hospital Cologne, University of Cologne, and the German Center for Infection Research, Partner Site Bonn-Cologne - both in Cologne, Germany (H.S.).
Background:
Ceftobiprole is a cephalosporin that may be effective for treating complicated Staphylococcus aureus bacteremia, including methicillin-resistant S. aureus.
Methods:
In this phase 3, double-blind, double-dummy, noninferiority trial, adults with complicated S. aureus bacteremia were randomly assigned in a 1:1 ratio to receive ceftobiprole at a dose of 500 mg intravenously every 6 hours for 8 days and every 8 hours thereafter, or daptomycin at a dose of 6 to 10 mg per kilogram of body weight intravenously every 24 hours plus optional aztreonam (at the discretion of the trial-site investigators). The primary outcome, overall treatment success 70 days after randomization (defined as survival, bacteremia clearance, symptom improvement, no new S. aureus bacteremia-related complications, and no receipt of other potentially effective antibiotics), with a noninferiority margin of 15%, was adjudicated by a data review committee whose members were unaware of the trial-group assignments. Safety was also assessed.
Results:
Of 390 patients who underwent randomization, 387 (189 in the ceftobiprole group and 198 in the daptomycin group) had confirmed S. aureus bacteremia and received ceftobiprole or daptomycin (modified intention-to-treat population). A total of 132 of 189 patients (69.8%) in the ceftobiprole group and 136 of 198 patients (68.7%) in the daptomycin group had overall treatment success (adjusted difference, 2.0 percentage points; 95% confidence interval [CI], -7.1 to 11.1). Findings appeared to be consistent between the ceftobiprole and daptomycin groups in key subgroups and with respect to 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 and 117 of 198 patients (59.1%) who received daptomycin; serious adverse events were reported in 36 patients (18.8%) and 45 patients (22.7%), respectively. Gastrointestinal adverse events (primarily mild nausea) were more frequent with ceftobiprole.
Conclusions:
Ceftobiprole was noninferior to daptomycin with respect to overall treatment success in patients with complicated S. aureus bacteremia. (Funded by Basilea Pharmaceutica International and the U.S. Department of Health and Human Services; ERADICATE ClinicalTrials.gov number, NCT03138733.).
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