Data are presented as No. (%) unless otherwise indicated. P value compares real-world vs MODIFY I/II study cohorts using a 2-sided t test and Pearson’s chi-square test.

Abbreviations: CDI, Clostridioides difficile infection; FMT, fecal microbiota transplant; PCR, polymerase chain reaction; SoC, standard of care.

^aPooled modified intention-to-treat population according to Wilcox et al. [11] and Gerding et al. [12].

^bDue to immunosuppressive medication or underlying disease (immune deficiency, solid organ or hematopoietic stem cell transplant, absolute neutrophil count <500 cells/μL).

^cDefined by any of the following: albumin ≤3.0 g/dL, serum creatinine ≥1.5 times above baseline, hypotension or shock, intensive care unit stay related to CDI, ileus, toxic megacolon or colectomy related to CDI, serum lactate >5 mmol/L, white blood cell count ≥15000 cells/μL.

^dAge ≥65 years, compromised immunity, current CDI with severe presentation, and CDI episodes experienced in past 6 months. Note, hypervirulent Clostridioides difficile strains were not available to assess as a CDI risk factor in this study; however, they were included in the MODIFY I/II trials.

^eDefined as serum creatinine ≥1.5 mg/dL.

^fDefined as mild, moderate, or severe liver disease as reported on the Charlson comorbidity index.