2022
DOI: 10.1093/ofid/ofac492.021
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730. A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ridinilazole Compared with Vancomycin for the Treatment of Clostridioides difficile Infection

Abstract: Background Vancomycin (VAN) therapy for C. difficile infection (CDI) is effective with > 80% clinical response (CR) but is associated with 20–30% recurrence rate (rCDI). Secondary bile acids (2° BAs) inhibit C. difficile germination and help prevent rCDI. VAN depletes the gut microbiome decreasing the conversion of primary bile acids to 2° BAs. Ridinilazole (RDZ) is a highly selective anti-CDI, DNA-binding antibiotic in development for the treatment of CDI and prevention of rCDI. … Show more

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Cited by 7 publications
(5 citation statements)
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“…Clinical development of ridinilazole is on hold due to the Phase 3 Ri-CoDIFy study results. In this study, ridinilazole treatment achieved a higher sustained clinical response compared to vancomycin; however, the study did not pass the statistical threshold for superiority and, as such, the primary endpoint was not achieved ( 19 ).…”
Section: Discussionmentioning
confidence: 63%
“…Clinical development of ridinilazole is on hold due to the Phase 3 Ri-CoDIFy study results. In this study, ridinilazole treatment achieved a higher sustained clinical response compared to vancomycin; however, the study did not pass the statistical threshold for superiority and, as such, the primary endpoint was not achieved ( 19 ).…”
Section: Discussionmentioning
confidence: 63%
“…56 However, the phase III study of ridinilazole failed to achieve superiority over vancomycin, though it did demonstrate reduced rates of CDI recurrence compared to vancomycin (8.1% vs 17.3%) and had a lesser impact on diversity of the intestinal microbiome. 57 Since it failed to achieve its primary endpoint, it is uncertain whether ridinilazole will cease development. While there is evidence that bacitracin, a gram positive antimicrobial, effectively neutralises C. difficile toxin and prevents epithelial damage in vitro, there is otherwise insufficient data to recommend use as monotherapy in the treatment of CDI.…”
Section: Additional Medic Ation Cons Ider Ationsmentioning
confidence: 99%
“…Ridinilazole is a novel investigative gut specific antibiotic that was found to be non‐inferior to vancomycin (66.7% compared to 42.4% sustained clinical response, respectively) in a phase II randomised double‐blind active‐controlled trial 56 . However, the phase III study of ridinilazole failed to achieve superiority over vancomycin, though it did demonstrate reduced rates of CDI recurrence compared to vancomycin (8.1% vs 17.3%) and had a lesser impact on diversity of the intestinal microbiome 57 . Since it failed to achieve its primary endpoint, it is uncertain whether ridinilazole will cease development.…”
Section: Additional Medication Considerationsmentioning
confidence: 99%
“…A third antibiotic, metronidazole (MTZ), is no longer a guideline recommended due to decreasing clinical response rates most likely due to antimicrobial resistance ( 5 , 6 ). Although novel therapeutics are in development for CDI, including the recent approval of live biotherapeutic products, only three antibiotics have made it to phase III trials since the approval of FDX in 2011, and none have filed for Food and Drug Administration approval ( 7 12 ). Thus, new antibiotics and particularly those with activity against multidrug-resistant (MDR) strains are urgently needed.…”
Section: Introductionmentioning
confidence: 99%