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

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ClinicalTrials.gov Identifier: NCT03760484
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Drug: Fidaxomicin 200 mg Biological: fecal microbiota transplantation (FMT) Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Serial Fecal Microbiota Transplant (FMT) Plus Fidaxomicin in the Treatment of Severe or Fulminant Clostridium Difficile Infection, With Detailed Characterization in Microbiota, Metabolomics and Host Immune Response
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : December 16, 2021
Estimated Study Completion Date : March 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
Drug Information available for: Fidaxomicin

Arm Intervention/treatment
Experimental: fecal transplant with fidaxomicin
FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days
Drug: Fidaxomicin 200 mg
Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.
Other Name: dificid

Biological: fecal microbiota transplantation (FMT)
Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles
Other Name: biotherapy




Primary Outcome Measures :
  1. CDI resolution- short term [ Time Frame: 2 weeks after final FMT ]
    <3 unformed bowel movements/24h or return to baseline bowel habit


Secondary Outcome Measures :
  1. Sustained CDI resolution [ Time Frame: 8 weeks after final FMT ]
    Lack of CDI recurrence

  2. Serious Adverse Event [ Time Frame: Up to 8 weeks after final FMT ]
    Death

  3. Serious Adverse Event [ Time Frame: Up to 8 weeks after final FMT ]
    Colonic perforation

  4. Serious Adverse Event [ Time Frame: Up to 8 weeks after final FMT ]
    Proven infection related to FMT

  5. Serious Adverse Event [ Time Frame: Up to 8 weeks after final FMT ]
    Hospitalization due to CDI subsequent to final FMT and discharge

  6. Surgical Intervention [ Time Frame: Up to 8 weeks after final FMT ]
    Colectomy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760484


Contacts
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Contact: Dina Kao, MD 780-492-8307 dkao@ualberta.ca
Contact: Lindsey Russell, MD larussel@ualberta.ca

Locations
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Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2X8
Contact: Dina Kao, MD    780 492 8307    dkao@ualberta.ca   
Contact: Lindsey Russell, MD    780 492 8307    larussel@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Dina Kao, MD University of Alberta

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03760484     History of Changes
Other Study ID Numbers: Pro00081229
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Alberta:
Fecal microbiota transplantation
Fidaxomicin

Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Fidaxomicin
Anti-Bacterial Agents
Anti-Infective Agents