drugset / Trial / NCT03760484

Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection

NCT03760484

Phase 2 Terminated 4 enrolled University of Alberta
NaSingle-groupOpen-labelTreatment

Summary

Fecal microbiota transplantation (FMT) has been very effective for patients who suffer from mild C diff infection (CDI) which recurs but it is unclear how effective FMT alone is in treating severe and fulminant CDI. Current evidence suggests that FMT in combination with vancomycin is required, and that multiple treatments are necessary. The investigators think fidaxomicin may be a better option in the context and may potentially reduce the number of FMT required. However, fidaxomicin has never been used to treat severe or fulminant CDI. In this pilot study, the investigators plan to use a combination of FMT plus fidaxomicin to determine efficacy and safety in treating patients with severe or fulminant CDI. The investigators want to see if this approach may reduce the number of FMT treatment required, and/or the length of hospital stay.

Timeline

Start
2019-01-21
Primary completion
2020-03-10
Completion
2020-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Fidaxomicin Other / unclassified 200 mg Oral