Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03760484
Other study ID # Pro00081229
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date January 21, 2019
Est. completion date March 10, 2020

Study information

Verified date October 2022
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date March 10, 2020
Est. primary completion date March 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Canada University of Alberta Hospital Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final 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) 8 weeks after final Fecal Microbiota Transplant (FMT)
Secondary Death Reported death 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days
Secondary Perforation Colonic perforation 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days
Secondary Infection Proven infection related final Fecal Microbiota Transplant (FMT) 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.
Secondary Hospitalization Hospitalization due to C. difficile infection (CDI) 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.
Secondary Colectomy Surgical Intervention - Colectomy 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.
See also
  Status Clinical Trial Phase
Completed NCT02896244 - AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment
Recruiting NCT06071312 - FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach Phase 1/Phase 2
Recruiting NCT01973465 - Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis N/A
Terminated NCT01048567 - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly Phase 2
Completed NCT01066221 - Comparative Study of Three Different Testing Mechanisms for Clostridium Difficile N/A
Not yet recruiting NCT03586206 - Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
Completed NCT02563106 - A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI Phase 2
Completed NCT02207140 - Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly Phase 0
Completed NCT02857582 - Transplantation of Cultured Gut Microflora to Repeat Antibiotic-induced Diarrhea Due to Clostridium Difficile Phase 2
Not yet recruiting NCT01942447 - Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis N/A
Active, not recruiting NCT01703494 - Fecal Transplant for Relapsing C. Difficile Infection Phase 2
Completed NCT01813500 - Host Immune Response to Clostridium Difficile Infection in Inflammatory Bowel Disease Patients N/A
Completed NCT01087892 - Probiotics in Preventing Antibiotic Associated Diarrhoea Including Clostridium Difficile Infection N/A
Suspended NCT00591357 - Efficacy of Loperamide for C. Difficile Colitis and Other Diarrheal Diseases Associated With Antibiotic Therapy Phase 4
Recruiting NCT00377078 - Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridium Difficile. N/A
Completed NCT02254967 - A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population Phase 4
Terminated NCT01775397 - A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System Phase 4
Terminated NCT03617172 - PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol Phase 2
Recruiting NCT05622721 - REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs
Completed NCT02437487 - SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI) Phase 2