Fecal Microbiota Transplantation Versus Vancomycin or Fidaxomicin in Clostridioides Difficile Infection First Recurrence

• Status: Not yet recruiting
• Trial end date: 2025-12-01

Summary

The clinical trial aims to evaluate the efficacy of fecal microbiota transplantation (FMT) vs the pragmatic use of standard of care treatment (either vancomycin or fidaxomicin) in severe and non-severe first recurrence of Clostridioides difficile infection (rCDI).

Experimental arm: antibiotic treatment (vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days, min 7) followed by FMT by oral capsules (one FMT, i.e. 15 FMT capsules given on 2 consecutive days, and followed by a mandatory 2nd FMT in severe rCDI, or by a 2nd FMT only in case of persisting symptoms in non-severe rCDI).

Control Arm: vancomycin or fidaxomicin as initially prescribed per SoC continued for 10 days.

• Phase: Phase 3

Details

• Lead Sponsor: Benoit Guery
• Treatments: Fidaxomicin; Vancomycin