Rezafungin versus caspofungin in a phase 2, randomized, double-blind study for the treatment of candidemia and invasive candidiasis: the STRIVE Trial
Open accessAbstract
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. In total, 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. Clinical Trials Registration: NCT02734862
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The safety of rezafungin in treating invasive candidiasis and the potential advantages of more rapid clearance of candidaemia were reported in the phase 2 STRIVE study.
“The safety of rezafungin in treating invasive candidiasis and the potential advantages of more rapid clearance of candidaemia were reported in the phase 2 STRIVE study.”
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- Authors
- Thompson, G. R., Soriano, A., Skoutelis, A., Vazquez, J. A., Honore, P. M., Horcajada, J. P., Spapen, H., Bassetti, M., Ostrosky-Zeichner, L., Das, A. F., Viani, R. M., Sandison, T., & Pappas, P. G.
- Affiliations
- University of California Davis Medical Center (US)
- Department of Infectious Diseases, Hospital Clínic de Barcelona, IDIBAPS, University of Barcelona, Spain
- Evangelismos Hospital (GR)
- Department of Medicine/Division of Infectious Disease, Medical College of Georgia/Augusta University, Augusta, Georgia, USA
- Department of Intensive Care, Brugmann University Hospital, Brussels, Belgium
- Universitat Autònoma de Barcelona (ES)
- Universitair Ziekenhuis Brussel (BE)
- Ospedale Policlinico San Martino (IT)
- Division of Infectious Diseases, McGovern Medical School, Houston, Texas, USA
- AD Stat Consulting, Guerneville, California, USA
- Cidara Therapeutics (United States) (US)
- University of Alabama at Birmingham (US)
- Corresponding author
- Thompson, George R
- Venue
- Clinical Infectious Diseases
- Publisher
- Oxford University Press (OUP)
- Published
- 2020-09-21
- Volume
- 73
- Issue
- 11
- Pages
- e3647-e3655
- ISSN
- 1058-4838 (ISSN-L)
- 1537-6591
- PMC
- PMC8662762
- OpenAlex
- W3087075670
- Cited by
- 163
- References
- 30
- Citations by year
- 2026: 21 · 2025: 32 · 2024: 38 · 2023: 30 · 2022: 19 · 2021: 21 · 2020: 2
- FWCI
- 2.36
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Clinical Infectious Diseases (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Repositori digital de la UPF (Universitat Pompeu Fabra) (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Funders
- Cidara Therapeutics, Inc
- Topics
- Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
- Health Sciences › Medicine › Epidemiology › Fungal Infections and Studies
- Life Sciences › Agricultural and Biological Sciences › Ecology, Evolution, Behavior and Systematics › Fungal Plant Pathogen Control
- Keywords
- rezafungin, caspofungin, candidemia, invasive candidiasis, echinocandins, antifungal treatment efficacy, all-cause mortality, STRIVE trial, dose comparison, adverse events, pharmacokinetics/pharmacodynamics, weekly dosing
- MeSH terms
- Caspofungin, Adult, Antifungal Agents, Double-Blind Method, Humans, Treatment Outcome, Echinocandins, Candidiasis, Invasive, Candidemia
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