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

NCT03760484 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: Pro00081229
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Clostridium Difficile

Keywords

Fecal microbiota transplantation; Fidaxomicin

Outcome Measures

Primary Outcomes (1)

• C Difficile Infection (CDI) Resolution- Short Term (Two 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)

  2 weeks after final Fecal Microbiota Transplant (FMT)

Secondary Outcomes (6)

• Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT))

  8 weeks after final Fecal Microbiota Transplant (FMT)

• Death

  8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days

• Perforation

  8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days

• Infection

  8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.

• Hospitalization

  8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.

Study Arms (1)

fecal transplant with fidaxomicin

EXPERIMENTAL

FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days

Drug: Fidaxomicin 200 mg; Biological: fecal microbiota transplantation (FMT)

Interventions

Fidaxomicin 200 mg DRUG

Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.

Also known as: dificid

fecal transplant with fidaxomicin

fecal microbiota transplantation (FMT) BIOLOGICAL

Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles

Also known as: biotherapy

fecal transplant with fidaxomicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2X8, Canada

Location

Related Publications (1)

• Monaghan TM, Duggal NA, Rosati E, Griffin R, Hughes J, Roach B, Yang DY, Wang C, Wong K, Saxinger L, Pucic-Bakovic M, Vuckovic F, Klicek F, Lauc G, Tighe P, Mullish BH, Blanco JM, McDonald JAK, Marchesi JR, Xue N, Dottorini T, Acharjee A, Franke A, Li Y, Wong GK, Polytarchou C, Yau TO, Christodoulou N, Hatziapostolou M, Wang M, Russell LA, Kao DH. A Multi-Factorial Observational Study on Sequential Fecal Microbiota Transplant in Patients with Medically Refractory Clostridioides difficile Infection. Cells. 2021 Nov 19;10(11):3234. doi: 10.3390/cells10113234.

  PMID: 34831456 BACKGROUND

MeSH Terms

Interventions

Fidaxomicin; Fecal Microbiota Transplantation; Biological Therapy

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Polyketides; Macrocyclic Compounds; Polycyclic Compounds; Therapeutics

Results Point of Contact

• Title: Dr. Dina Kao
• Organization: University of Alberta

dina.kao@ualberta.ca

780-233-6025

Study Officials

• Dina Kao, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 30, 2018
• Study Start: January 21, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: December 13, 2022
• Results First Posted: December 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)