Safety and Efficacy of Fecal Microbiota, Live-jslm, in Preventing Recurrent Clostridioides difficile Infection in Participants Who Were Mildly to Moderately Immunocompromised in the Phase 3 PUNCH CD3-OLS Study

作者：Carolyn D. Alonso, Glenn Tillotson, Monique R. Bidell, Beth Guthmueller, Frederikke Hoeyer, Monika Fischer, Erik R. Dubberke · 发表于：Open Forum Infectious Diseases · 年份：2025 · DOI：10.1093/ofid/ofaf117 · 被引用次数：8 · 研究领域：Clostridium difficile and Clostridium perfringens research、Gut microbiota and health、Nosocomial Infections in ICU

Abstract Background Fecal microbiota, live-jslm (RBL; Rebyota), is the first Food and Drug Administration–approved, single-dose, microbiota–based live biotherapeutic to prevent recurrent Clostridioides difficile infection (rCDI) in adults following standard-of-care antimicrobials. Patients who are immunocompromised are often considered at higher risk for C difficile infection, including recurrence, as compared with those who are immunocompetent. This subgroup analysis of PUNCH CD3-OLS (NCT03931941) evaluated RBL safety and efficacy in participants with rCDI who were considered mildly to moderately immunocompromised. Methods Participants with rCDI who had immunocompromising conditions and/or were taking immunosuppressive medications were included. Treatment-emergent adverse events (TEAEs) were collected for up to 6 months following RBL administration. Efficacy outcomes included treatment success at 8 weeks and sustained clinical response at 6 months. Results Overall, 793 participants were enrolled in PUNCH CD3-OLS and 697 received RBL; 141 were included in the immunocompromised subgroup. TEAEs within 8 weeks were reported by 44.7% and 48.0% of participants in the immunocompromised and nonimmunocompromised subgroups, respectively; most events were mild or moderate gastrointestinal disorders. Serious TEAEs within 8 weeks were reported by 4.3% and 3.8% of participants in the immunocompromised and nonimmunocompromised subgroups. No RBL-related systemic infections occurred. In the ...