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Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia.

Publication ,  Journal Article
Holland, TL; Cosgrove, SE; Doernberg, SB; Jenkins, TC; Turner, NA; Boucher, HW; Pavlov, O; Titov, I; Kosulnykov, S; Atanasov, B; Poromanski, I ...
Published in: The New England journal of medicine
October 2023

Ceftobiprole is a cephalosporin that may be effective for treating complicated Staphylococcus aureus bacteremia, including methicillin-resistant S. aureus.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.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.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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Published In

The New England journal of medicine

DOI

EISSN

1533-4406

ISSN

0028-4793

Publication Date

October 2023

Volume

389

Issue

15

Start / End Page

1390 / 1401

Related Subject Headings

  • Treatment Outcome
  • Staphylococcus aureus
  • Staphylococcal Infections
  • Methicillin-Resistant Staphylococcus aureus
  • Humans
  • General & Internal Medicine
  • Double-Blind Method
  • Daptomycin
  • Cephalosporins
  • Bacteremia
 

Citation

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Holland, T. L., Cosgrove, S. E., Doernberg, S. B., Jenkins, T. C., Turner, N. A., Boucher, H. W., … ERADICATE Study Group, . (2023). Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia. The New England Journal of Medicine, 389(15), 1390–1401. https://doi.org/10.1056/nejmoa2300220
Holland, Thomas L., Sara E. Cosgrove, Sarah B. Doernberg, Timothy C. Jenkins, Nicholas A. Turner, Helen W. Boucher, Oleksander Pavlov, et al. “Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia.The New England Journal of Medicine 389, no. 15 (October 2023): 1390–1401. https://doi.org/10.1056/nejmoa2300220.
Holland TL, Cosgrove SE, Doernberg SB, Jenkins TC, Turner NA, Boucher HW, et al. Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia. The New England journal of medicine. 2023 Oct;389(15):1390–401.
Holland, Thomas L., et al. “Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia.The New England Journal of Medicine, vol. 389, no. 15, Oct. 2023, pp. 1390–401. Epmc, doi:10.1056/nejmoa2300220.
Holland TL, Cosgrove SE, Doernberg SB, Jenkins TC, Turner NA, Boucher HW, Pavlov O, Titov I, Kosulnykov S, Atanasov B, Poromanski I, Makhviladze M, Anderzhanova A, Stryjewski ME, Assadi Gehr M, Engelhardt M, Hamed K, Ionescu D, Jones M, Saulay M, Smart J, Seifert H, Fowler VG, ERADICATE Study Group. Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia. The New England journal of medicine. 2023 Oct;389(15):1390–1401.

Published In

The New England journal of medicine

DOI

EISSN

1533-4406

ISSN

0028-4793

Publication Date

October 2023

Volume

389

Issue

15

Start / End Page

1390 / 1401

Related Subject Headings

  • Treatment Outcome
  • Staphylococcus aureus
  • Staphylococcal Infections
  • Methicillin-Resistant Staphylococcus aureus
  • Humans
  • General & Internal Medicine
  • Double-Blind Method
  • Daptomycin
  • Cephalosporins
  • Bacteremia