Treatment Outcomes Among Patients With a Positive Candida Culture Close to Randomization Receiving Rezafungin or Caspofungin in the ReSTORE Study
Issued Date
2024-09-26
Resource Type
eISSN
15376591
Scopus ID
2-s2.0-85205275022
Pubmed ID
38985561
Journal Title
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Volume
79
Issue
3
Start Page
672
End Page
681
Rights Holder(s)
SCOPUS
Bibliographic Citation
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Vol.79 No.3 (2024) , 672-681
Suggested Citation
Soriano A., Honore P.M., Cornely O.A., Chayakulkeeree M., Bassetti M., Haihui H., Dupont H., Kim Y.K., Kollef M., Kullberg B.J., Manamley N., Pappas P., Pullman J., Sandison T., Dignani C., Vazquez J.A., Thompson G.R. Treatment Outcomes Among Patients With a Positive Candida Culture Close to Randomization Receiving Rezafungin or Caspofungin in the ReSTORE Study. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Vol.79 No.3 (2024) , 672-681. 681. doi:10.1093/cid/ciae363 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/101498
Title
Treatment Outcomes Among Patients With a Positive Candida Culture Close to Randomization Receiving Rezafungin or Caspofungin in the ReSTORE Study
Author's Affiliation
Centro de Investigación Biomédica en Red de Enfermedades Infecciosas
Siriraj Hospital
CHU UCL Namur
IRCCS San Martino Polyclinic Hospital
Augusta University
The University of Alabama at Birmingham
Università degli Studi di Genova
Universität zu Köln
Washington University in St. Louis
Fudan University
Uniklinik Köln
Yonsei University Wonju College of Medicine
UC Davis Medical Center
CHU Amiens Picardie
Radboud University Medical Center
Universitat de Barcelona
Cidara Therapeutics
Mundipharma Research Limited
Mercury Street Medical Group
Siriraj Hospital
CHU UCL Namur
IRCCS San Martino Polyclinic Hospital
Augusta University
The University of Alabama at Birmingham
Università degli Studi di Genova
Universität zu Köln
Washington University in St. Louis
Fudan University
Uniklinik Köln
Yonsei University Wonju College of Medicine
UC Davis Medical Center
CHU Amiens Picardie
Radboud University Medical Center
Universitat de Barcelona
Cidara Therapeutics
Mundipharma Research Limited
Mercury Street Medical Group
Corresponding Author(s)
Other Contributor(s)
Abstract
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.