Rezafungin versus Caspofungin in a phase 2, randomized, double-blind study for the treatment of candidemia and invasive candidiasis - the STRIVE trial
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- dc.contributor.author Thompson, George R.
- dc.contributor.author Soriano, Alex
- dc.contributor.author Skoutelis, Athanasios
- dc.contributor.author Vazquez, Jose A.
- dc.contributor.author Honore, Patrick M.
- dc.contributor.author Horcajada Gallego, Juan Pablo
- dc.contributor.author Spapen, Herbert
- dc.contributor.author Bassetti, Matteo
- dc.contributor.author Ostrosky-Zeichner, Luis
- dc.contributor.author Das, Anita F.
- dc.contributor.author Viani, Rolando M.
- dc.contributor.author Sandison, Taylor
- dc.contributor.author Pappas, Peter G.
- dc.date.accessioned 2021-06-15T06:53:40Z
- dc.date.issued 2021
- dc.description.abstract Background: Rezafungin (RZF) is a novel echinocandin exhibiting distinctive pharmacokinetics/pharmacodynamics. STRIVE was a phase 2, double-blind, randomized trial designed to compare the safety and efficacy of RZF once weekly (QWk) to caspofungin (CAS) once daily for treatment of candidemia and/or invasive candidiasis (IC). Methods: Adults with systemic signs and mycological confirmation of candidemia and/or IC were randomized to RZF 400 mg QWk (400 mg), RZF 400 mg on week 1 then 200 mg QWk (400/200 mg), or CAS 70 mg as a loading dose followed by 50 mg daily for ≤ 4 weeks. Efficacy assessments included overall cure (resolution of signs of candidemia/IC + mycological eradication) at day 14 (primary endpoint), investigator-assessed clinical response at day 14, and 30-day all-cause mortality (ACM) (secondary endpoints), and time to negative blood culture. Safety was evaluated by adverse events and ACM through follow-up. Results: Of 207 patients enrolled, 183 were in the microbiological intent-to-treat population (~21% IC). Overall cure rates were 60.5% (46/76) for RZF 400 mg, 76.1% (35/46) for RZF 400/200 mg, and 67.2% (41/61) for CAS; investigator-assessed clinical cure rates were 69.7% (53/76), 80.4% (37/46), and 70.5% (43/61), respectively. 30-day ACM was 15.8% for RZF 400 mg, 4.4% for RZF 400/200 mg, and 13.1% for CAS. Candidemia was cleared in 19.5 and 22.8 hours in RZF and CAS patients, respectively. No concerning safety trends were observed; ACM through follow-up was 15.2% (21/138) for RZF and 18.8% (13/69) for CAS. Conclusions: RZF was safe and efficacious in the treatment of candidemia and/or IC.
- dc.format.mimetype application/pdf
- dc.identifier.citation Thompson GR, Soriano A, Skoutelis A, Vazquez JA, Honore PM, Horcajada JP, et al. Rezafungin versus Caspofungin in a phase 2, randomized, double-blind study for the treatment of candidemia and invasive candidiasis - the STRIVE trial. Clin Infect Dis. 2021 Dec 6;73(11):e3647-55. DOI: 10.1093/cid/ciaa1380
- dc.identifier.doi http://dx.doi.org/10.1093/cid/ciaa1380
- dc.identifier.issn 1058-4838
- dc.identifier.uri http://hdl.handle.net/10230/47875
- dc.language.iso eng
- dc.publisher Oxford University Press
- dc.rights © Oxford University Press. This is a pre-copyedited, author-produced version of an article accepted for publication in Clinical infectious diseases following peer review. The version of record Thompson GR, Soriano A, Skoutelis A, Vazquez JA, Honore PM, Horcajada JP, et al. Rezafungin versus Caspofungin in a phase 2, randomized, double-blind study for the treatment of candidemia and invasive candidiasis - the STRIVE trial. Clin Infect Dis. 2020 Sep 21: ciaa1380 is available online at: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa1380/5909460, http://dx.doi.org/10.1093/cid/ciaa1380
- dc.rights.accessRights info:eu-repo/semantics/openAccess
- dc.subject.keyword Candidemia
- dc.subject.keyword Echinocandins
- dc.subject.keyword Rezafungin
- dc.subject.keyword Systemic antifungal therapy
- dc.title Rezafungin versus Caspofungin in a phase 2, randomized, double-blind study for the treatment of candidemia and invasive candidiasis - the STRIVE trial
- dc.type info:eu-repo/semantics/article
- dc.type.version info:eu-repo/semantics/acceptedVersion