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

Soriano, Alex;Honoré, Patrick;Cornely, Oliver A;Chayakulkeeree, Methee;Thompson Iii, George R;et.al.
(2024) Clinical infectious diseases : an official publication of the Infectious Diseases Society of America — Vol. 79, n° 3, p. 672-681 (2024)

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  • Soriano, Alexorcid-logo
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  • Honoré, Patrickorcid-logoUCLouvain
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  • Cornely, Oliver Aorcid-logo
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  • Chayakulkeeree, Metheeorcid-logo
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  • Thompson Iii, George Rorcid-logo
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Abstract
(en) 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.
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Soriano, A., Honoré, P., 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 Iii, G. R. (2024). 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, 79(3), 672-681. https://doi.org/10.1093/cid/ciae363 (Original work published 2024)