ReSTORE and STRIVE
Trial question
Is rezafungin noninferior to caspofungin in patients with candidemia or invasive candidiasis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 294
294 patients (114 female, 180 male).
Inclusion criteria: adult patients with candidemia or invasive candidiasis.
Key exclusion criteria: septic arthritis in a prosthetic joint; osteomyelitis; endocarditis or myocarditis; meningitis, endophthalmitis, or any CNS infection.
Interventions
N=139 rezafungin (at a loading dose of 400 mg on day 1, then 200 mg on day 8 plus an optional 200 mg dose on day 15 or 22).
N=155 caspofungin (at a loading dose of 70 mg on day 1, then 50 mg daily for at least 3 and up to 21 or 28 days).
Primary outcome
Rate of 30-day all-cause mortality
18.7%
19.4%
19.4 %
14.5 %
9.7 %
4.8 %
0.0 %
Rezafungin
Caspofungin
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the rate of 30-day all-cause mortality (18.7% vs. 19.4%; ARD -1.5, 95% CI -10.7 to 7.7).
Secondary outcomes
No significant difference in the rate of mycological eradication by day 5 (73% vs. 65%; AD 10%, 95% CI -0.3 to 20.4).
No significant difference in the rate of mycological eradication by day 14 (72% vs. 68%; AD 4.3%, 95% CI -6.2 to 14.7).
No significant difference in global cure at day 14 (65% vs. 63%; AD 2.3%, 95% CI -8.2 to 13.9).
Safety outcomes
No significant difference in treatment-emergent adverse event.
Conclusion
In adult patients with candidemia or invasive candidiasis, rezafungin was noninferior to caspofungin with respect to the rate of 30-day all-cause mortality.
Reference
George R Thompson rd, Alex Soriano, Patrick M Honore et al. Efficacy and safety of rezafungin and caspofungin in candidaemia and invasive candidiasis: pooled data from two prospective randomised controlled trials. Lancet Infect Dis. 2024 Mar;24(3):319-328.
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