Treatment Outcomes Among Patients With a Positive Candida Culture Close to Randomization Receiving Rezafungin or Caspofungin in the ReSTORE Study.

Autor:	Soriano A; Hospital Clínic de Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain.; CIBERINF, CIBER of Infectious Diseases, Madrid, Spain., Honore PM; CHU UCL Godinne Namur, UCL Louvain Medical School, Campus Godinne, Namur, Belgium., Cornely OA; Faculty of Medicine Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Cologne, Germany.; Department I of Internal Medicine, Excellence Center for Medical Mycology (ECMM) and German Center for Infection Research (DZIF), Partner Site Bonn-Cologne, University Hospital Cologne, Cologne, Germany., Chayakulkeeree M; Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand., Bassetti M; Infectious Diseases Unit, IRCCS San Martino Polyclinic Hospital, Genoa, Italy.; Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy., Haihui H; Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China., Dupont H; Amiens-Picardie University Hospital, Amiens, France., Kim YK; Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, South Korea., Kollef M; Washington University, St. Louis, Missouri, USA., Kullberg BJ; Radboud University Medical Center, Nijmegen, The Netherlands., Manamley N; Mundipharma Research Limited, Cambridge, United Kingdom., Pappas P; University of Alabama at Birmingham, Birmingham, Alabama, USA., Pullman J; Mercury Street Medical, Butte, Montana, USA., Sandison T; Cidara Therapeutics, Inc., San Diego, California, USA., Dignani C; PSI-CRO, Durham, North Carolina, USA., Vazquez JA; Augusta University, Augusta, Georgia, USA., Thompson GR 3rd; University of California Davis Medical Center, Sacramento, California, USA.
Jazyk:	angličtina
Zdroj:	Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2024 Sep 26; Vol. 79 (3), pp. 672-681.
DOI:	10.1093/cid/ciae363
Abstrakt:	Background: Rezafungin, a novel, once-weekly echinocandin for the treatment of candidemia and/or invasive candidiasis (IC) was noninferior to caspofungin for day 30 all-cause mortality (ACM) and day 14 global cure in the phase 3 ReSTORE trial (NCT03667690). We conducted preplanned subgroup analyses for patients with a positive culture close to randomization in ReSTORE. Methods: ReSTORE was a multicenter, double-blind, double-dummy, randomized trial in patients aged ≥18 years with candidemia and/or IC treated with once-weekly intravenous rezafungin (400 mg/200 mg) or once-daily intravenous caspofungin (70 mg/50 mg). This analysis comprised patients with a positive blood culture drawn between 12 hours before and 72 hours after randomization or a positive culture from another normally sterile site sampled between 48 hours before and 72 hours after randomization. Efficacy endpoints included day 30 ACM, day 14 global cure rate, and day 5 and 14 mycological response. Adverse events were evaluated. Results: This analysis included 38 patients randomized to rezafungin and 46 to caspofungin. In the rezafungin and caspofungin groups, respectively, day 30 ACM was 26.3% and 21.7% (between-group difference [95% confidence interval], 4.6% [-13.7%, 23.5%]), day 14 global response was 55.3% and 50.0% (between-group difference, 5.3% [-16.1%, 26.0%]), and day 5 mycological eradication was 71.1% and 50.0% (between-group difference, 21.1% [-0.2%, 40.2%]). Safety was comparable between treatments. Conclusions: These findings support the efficacy and safety of rezafungin compared with caspofungin for the treatment of candidemia and/or IC in patients with a positive culture close to randomization, with potential early treatment benefits for rezafungin. Competing Interests: Potential conflicts of interest. A. S.: grants from Pfizer and Gilead and honoraria for lectures and advisory boards from Pfizer, MSD, Shionogi, Angelini, and Menarini. P. M. H.: grants or contracts from Baxter, Cytosorbents, and Pfizer; consulting fees from Baxter, Cytosorbents, and Pfizer; honoraria from Baxter and Cytosorbents; and support for attending meetings from Mundipharma and Pfizer, outside of the submitted work. O. A. C.: grants or contracts from Cidara, F2G, Gilead, MedPace, MSD, Mundipharma, Pfizer, and Scynexis; consulting fees from AbbVie, AiCuris, Cidara, Gilead, IQVIA, Matinas, MedPace, Pfizer, PSI, and Scynexis; honoraria for lectures from Abbott, AbbVie, Al-Jazeera Pharmaceuticals/Hikma, Gilead, Grupo Biotoscana/United Medical/Knight, Medscape, medupdate, Merck/MSD, Noscendo, Pfizer, and Shionogi; payment for expert testimony from Cidara; participation on a Data and Safety Monitoring Board or advisory board from Cidara, IQVIA, Janssen, Medpace, PSI, Pulmocide, and Shionogi. M. C.: research funding from F2G, Cidara, Shionogi, Pfizer, AstraZeneca, and Janssen, and served as a speaker and advisory board membership for Gilead, Pfizer, and MSD. M. B.: consulting fees and payment or honoraria for lectures, presentations, speaker bureaus, manuscript writing, or educational events from MSD, Pfizer, Menarini, Shionogi, Angelini, and Gilead; and Data and Safety Monitoring Board or advisory board participation for Cidara and Mundipharma. H. D.: fees from Mundipharma for serving on expert boards and conferences. M. K.: funding from the Barnes-Jewish Hospital Foundation. B. J. K.: served on the independent data review committee for Cidara. N. M.: is an employee of Mundipharma Research Ltd. P. P.: grants from and data review committee membership for Cidara and Melinta; grants from Astellas, Scynexis, and Merck; and advisory board membership for F2G and Matinas. T. S.: employee and shareholder of Cidara Therapeutics. J. A. V.: research and consulting for Astellas, Amplyx, Cidara, F2G, Melinta, and Scynexis and served on the Data and Safety Monitoring Board for F2G. G. R. T.: research and consulting for Astellas, Amplyx, Cidara, F2G, Mayne, Melinta, Mundipharma, and Scynexis and served on the Data and Safety Monitoring Board for Pfizer. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
Databáze:	MEDLINE
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