Patients with CDI given ridinilazole had sustained clinical response, fewer recurrences
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WASHINGTON — Nearly three out of every four patients with Clostridioides difficile infection being treated with ridinilazole had a sustained clinical response, according to data presented at IDWeek.
“In addition to being effective for the treatment of C. difficile infection (CDI), there is a need for agents that can prevent CDI recurrences,” Pablo C. Okhuysen, MD, professor at the University of Texas MD Anderson Cancer Center told Healio. “A key factor predisposing to CDI recurrences is the intestinal dysbiosis that results from the use of nonselective antibiotics against CDI that also disrupt the microbiome.”
One potential option, ridinilazole, was assessed by Okhuysen and colleagues through a global, double-blinded, randomized phase 3 trial. Patients were randomly assigned to receive a 10-day treatment with ridinilazole or vancomycin for CDI treatment. According to the study, the primary endpoint was sustained clinical response (SCR), defined as no recurrent CDI (rCDI) through 30 days after the end of treatment. Additionally, all study participants were monitored for treatment-emergent adverse events.
Overall, 745 patients were included in the study — 370 of whom received ridinilazole and 375 of whom received vancomycin. Study data showed that ridinilazole achieved a numerically higher SCR rate than vancomycin (73% vs. 70.7%). Additionally, treatment with ridinilazole resulted in a significant reduction in rCDI rate (8.1% vs. 17.3%). An analysis of a prespecified subpopulation showed that reduction in rCDI rates were most notable in patients not receiving other antibiotics (6.7% in ridinilazole vs. 16.5% in vancomycin).
Additional study data showed that microbiome alpha diversity was higher for ridinilazole compared with vancomycin at end of treatment, as well as at 30 days after end of treatment (P < .0001 and P .0007 respectively) and relative abundance (P < .0001 and P = .0203, respectively).
“Ridinilazole selectively targets C. difficile and spares the the gut microbiome [and compared with] vancomycin, ridinilazole treatment resulted in fewer recurrences,” Okhuysen concluded.
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