Extended-pulsed fidaxomicin versus conventional dosing in patients at high risk of recurrence of Clostridioides difficile infection: a multicentre cohort study

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OBJECTIVES: Fidaxomicin has consistently shown lower recurrence rates than vancomycin for Clostridioides difficile infection (CDI), with the fidaxomicin extended-pulsed dosage (FEPD) achieving rates as low as 6% in a comparative trial, suggesting potential superiority over conventional fidaxomicin dosing (FCD). A subsequent single-centre retrospective study reported no significant difference between FEPD and FCD, possibly due to limited sample size. This study aims to compare CDI recurrence rates within 12 weeks after treatment completion between patients treated with FEPD and those receiving FCD in a large multicentre cohort. METHODS: A retrospective multicentre cohort study was conducted across 19 Spanish centres, including all CDI cases treated with fidaxomicin at either dosage between January 2021 and April 2023. To assess recurrence, a propensity score (PS)-matching analysis was performed, adjusting for potential confounders and prognostic factors for recurrence. Sensitivity analyses included inverse probability of treatment weighting (IPTW), exclusion of bezlotoxumab-treated patients, adjustment for immortal time bias, and competing-risks analysis. RESULTS: Of 1465 episodes evaluated, 991 were analysed: 726 (73.3%) received FCD and 265 (26.7%) FEPD. Crude recurrence rates in the FCD and FEPD regimens were 12.7% and 12.8%, respectively (OR: 1.01; 95% CI: 0.67-1.54; p 0.95). In the PS-matched analysis (263 per group), no significant difference was observed (OR: 1.04; 95% CI: 0.62-1.74; p 0.895), nor after IPTW adjustment (OR: 0.90; 95% CI: 0.59-1.39; p 0.644). Additional sensitivity and subgroup analyses yielded consistent results. Median time to recurrence from the end of treatment was 25 days (interquartile range: 15-44), similar among groups. CONCLUSIONS: This large multicentre cohort study suggests similar effectiveness of both fidaxomicin regimens for preventing CDI recurrence in real-world clinical practice. Time to recurrence from the end of treatment was similar in both groups. Randomised controlled trials are needed to confirm these findings.

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