An open-label, randomized trial comparing fidaxomicin to oral vancomycin for the treatment of Clostridioides difficile infection in hospitalized patients receiving concomitant antibiotics for concurrent infections

Link to article at PubMed

Clin Infect Dis. 2023 Oct 5:ciad606. doi: 10.1093/cid/ciad606. Online ahead of print.


BACKGROUND: Recurrent Clostridioides difficile infection (rCDI) occurs frequently, and concomitant antibiotic (CA) during the initial episode for treatment of non-C. difficile infection is a major risk factor. We sought to address the comparative efficacy of fidaxomicin vs. vancomycin in the setting of CA during the initial CDI episode.

METHODS: We conducted a randomized, controlled, open-label trial at two hospitals in Ann Arbor, MI. We consecutively consented and enrolled hospitalized patients ≥18 years old with diarrhea, a positive test for C. difficile, and ≥1 qualifying CA. Complicated CDI, CDI treatment for >24 hours prior to enrollment, and planned long-term (>12 weeks) CA use were notable exclusions.Clinical cure was defined as resolution of diarrhea for 2 consecutive days maintained until 2 days after therapy, and rCDI as recurrent diarrhea with positive testing ≤30 days after initial treatment. Patients were randomized to fidaxomicin or vancomycin.

RESULTS: Baseline characteristics were similar in the two groups of 144 subjects. Rates of clinical cure (73% vs. 62.9%, P = .195) and rCDI (3.3% vs 4.0%; P > .99) were similar for fidaxomicin and vancomycin in the intention to treat and per protocol cohorts, respectively. Only four subjects developed rCDI.

CONCLUSIONS: In this study of patients with CDI receiving CA, a numerically higher proportion were cured with fidaxomicin vs. vancomycin, but this result did not reach statistical significance. Overall recurrence was lower than anticipated in both arms compared to previous studies that did not extend duration of CDI treatment during CA.

PMID:37797310 | DOI:10.1093/cid/ciad606

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