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

Phase 2

Terminated

• Conditions: Clostridium Difficile
• Interventions: Drug: Fidaxomicin 200 mg; Biological: fecal microbiota transplantation (FMT)

• Registration Number: NCT03760484
• Lead Sponsor: University of Alberta

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 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.

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 who have severe or fulminant CDI not responding to maximal medical therapy. The hypothesis is the combination of FMT plus fidaxomicin can reduce the number of FMT required and/or hospital length of stay compared to FMT plus vancomycin.

Participants will receive FMT by enemas over 3 days which constitutes a single cycle with concurrent treatment with oral fidaxomicin. If participants do not show improvement biochemically or clinically, then a repeat FMT cycle will be administered to a maximum of 4 cycles.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-30
• Study Start: 2019-01-21
• Primary Completion: 2020-03-10
• Study Completion: 2020-03-10
• Results First Submitted: 2022-09-14
• Status Verified: 2022-10
• Results First Submitted QC: 2022-11-16
• Last Update Submitted: 2022-11-16
• Results First Posted: 2022-12-13
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fecal transplant with fidaxomicin	Fidaxomicin 200 mg	FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days
fecal transplant with fidaxomicin	fecal microbiota transplantation (FMT)	FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days

Primary Outcome Measures

Name	Time	Method
C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT))	2 weeks after final Fecal Microbiota Transplant (FMT)	Defined as \<3 unformed bowel movements/24h or return to baseline bowel habit 2 weeks after final Fecal Microbiota Transplant (FMT)

Secondary Outcome Measures

Name	Time	Method
Colectomy	8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.	Surgical Intervention - Colectomy
Hospitalization	8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.	Hospitalization due to C. difficile infection (CDI)
Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT))	8 weeks after final Fecal Microbiota Transplant (FMT)	Sustained C difficile infection (CDI) resolution defined as lack of C difficile infection (CDI) recurrence 8 weeks after final Fecal Microbiota Transplant (FMT)
Death	8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days	Reported death
Perforation	8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days	Colonic perforation
Infection	8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.	Proven infection related final Fecal Microbiota Transplant (FMT)

Trial Locations

Locations (1)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada