Status:
TERMINATED
Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection
Lead Sponsor:
University of Alberta
Conditions:
Clostridium Difficile
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
In this prospective, open -label, multi--center feasibility study, the investigators aim to determine the efficacy and safety of using combined serial FMT by enema plus fidaxomicin to treat patients w...
Eligibility Criteria
Inclusion
- Age \> 18 years with severe1 or fulminant2 CDI, without an adequate response to metronidazole IV 500 mg q8H and vancomycin 500 mg PO q6h for at least 2 days or after Fecal Microbiota Transplant (FMT). An adequate response is defined as a decrease in stool frequency or inflammatory markers (WBC or C reactive protein) by 10% over 48 hours
- Those with ability to provide informed consent or an alternative decision maker providing assent
Exclusion
- Those with bowel perforation
- Those taking chemotherapy or radiation treatment with absolute neutrophil count of \< 1000 cells/mm3
- Those with known colonic strictures
- Those with subtotal colectomy or planning to have a colectomy
- Those with significant ileus
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03760484
Start Date
January 21 2019
End Date
March 10 2020
Last Update
December 13 2022
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8