Ri-CoDIFy 1
Trial question
What is the role of ridinilazole in patients with C. difficile infection?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
59.0% female
41.0% male
N = 745
745 patients (436 female, 309 male).
Inclusion criteria: adult patients with C. difficile infection, confirmed with a stool toxin.
Key exclusion criteria: > 1 episode of C. difficile infection within the last 3 months or > 3 C. difficile infection episodes within the last 12 months.
Interventions
N=370 ridinilazole (at a dose of 200 mg BID for 10 days).
N=375 vancomycin (at a dose of 125 mg 4 times daily for 10 days).
Primary outcome
Sustained clinical response
73%
70.7%
73.0 %
54.8 %
36.5 %
18.3 %
0.0 %
Ridinilazole
Vancomycin
No significant
difference ↔
No significant difference in sustained clinical response (73% vs. 70.7%; AD 2.2%, 95% CI -4.2 to 8.6).
Secondary outcomes
Significant decrease in recurrent C. difficile infection (8.1% vs. 17.3%; ARD -9.2, 95% CI -14.1 to -4.5).
Significant increase in clinical response (86.5% vs. 92.3%; AD 6.2%, 95% CI 1.6 to 10.8).
Significantly greater improvement in secondary bile acids at day 40 (92.35% vs. 79.69%; AD 12.66%, 95% CI 1.98 to 23.34).
Safety outcomes
No significant difference in treatment-emergent adverse events.
Conclusion
In adult patients with C. difficile infection, confirmed with a stool toxin, ridinilazole was not superior to vancomycin with respect to sustained clinical response.
Reference
Pablo C Okhuysen, Mayur S Ramesh, Thomas Louie et al. A Randomized, Double-Blind, Phase 3 Safety and Efficacy Study of Ridinilazole Versus Vancomycin for Treatment of Clostridioides difficile Infection: Clinical Outcomes With Microbiome and Metabolome Correlates of Response. Clin Infect Dis. 2024 Jun 14;78(6):1462-1472.
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