Trial Outcomes & Findings for Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection (NCT NCT03760484)

NCT ID: NCT03760484

Last Updated: 2022-12-13

Results Overview

Defined as \<3 unformed bowel movements/24h or return to baseline bowel habit 2 weeks after final Fecal Microbiota Transplant (FMT)

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: 2 weeks after final Fecal Microbiota Transplant (FMT)
• Results posted on: 2022-12-13

Participant Flow

Participant milestones

Measure	Fecal Transplant With Fidaxomicin FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days 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. 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
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Fecal Transplant With Fidaxomicin n=4 Participants FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days 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. 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
Age, Customized 60-69 years	1 Participants n=93 Participants
Age, Customized 70-79 years	1 Participants n=93 Participants
Age, Customized 80+ years	2 Participants n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment Canada	4 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure

Fecal Transplant With Fidaxomicin n=4 Participants FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days 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. 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

C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT))

4 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure

Fecal Transplant With Fidaxomicin n=4 Participants FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days 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. 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

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

3 Participants

SECONDARY outcome

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

Reported death

Outcome measures

Measure

Fecal Transplant With Fidaxomicin n=4 Participants FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days 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. 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

Death

0 Participants

SECONDARY outcome

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

Colonic perforation

Outcome measures

Measure

Fecal Transplant With Fidaxomicin n=4 Participants FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days 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. 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

Perforation

0 Participants

SECONDARY outcome

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

Proven infection related final Fecal Microbiota Transplant (FMT)

Outcome measures

Measure

Fecal Transplant With Fidaxomicin n=4 Participants FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days 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. 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

Infection

0 Participants

SECONDARY outcome

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

Hospitalization due to C. difficile infection (CDI)

Outcome measures

Measure

Fecal Transplant With Fidaxomicin n=4 Participants FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days 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. 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

Hospitalization

0 Participants

SECONDARY outcome

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

Surgical Intervention - Colectomy

Outcome measures

Measure

Fecal Transplant With Fidaxomicin n=4 Participants FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days 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. 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

Colectomy

0 Participants

Adverse Events

Fecal Transplant With Fidaxomicin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dina Kao

University of Alberta

Phone: 780-233-6025

Email: dina.kao@ualberta.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place