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Difficulty enrolling participants/COVID pandemic/lack of continued in-kind support from product manufacturer.
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fecal transplant with fidaxomicin | Experimental | FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dina Kao, MD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34831456 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Count of Participants | Participants | 2 weeks after final Fecal Microbiota Transplant (FMT) |
|
8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dina Kao | University of Alberta | 780-233-6025 | dina.kao@ualberta.ca |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 21, 2020 | Nov 2, 2022 | Prot_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 17, 2020 | Oct 12, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000077732 | Fidaxomicin |
| D000069467 | Fecal Microbiota Transplantation |
| D001691 | Biological Therapy |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061065 | Polyketides |
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|
| 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 |
|
|
| Death |
Reported death |
| 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days |
| Perforation | Colonic perforation | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days |
| Infection | Proven infection related final Fecal Microbiota Transplant (FMT) | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days. |
| Hospitalization | Hospitalization due to C. difficile infection (CDI) | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days. |
| Colectomy | Surgical Intervention - Colectomy | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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) | Posted | Count of Participants | Participants | 8 weeks after final Fecal Microbiota Transplant (FMT) |
|
|
|
| Secondary | Death | Reported death | Posted | Count of Participants | Participants | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days |
|
|
|
| Secondary | Perforation | Colonic perforation | Posted | Count of Participants | Participants | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days |
|
|
|
| Secondary | Infection | Proven infection related final Fecal Microbiota Transplant (FMT) | Posted | Count of Participants | Participants | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days. |
|
|
|
| Secondary | Hospitalization | Hospitalization due to C. difficile infection (CDI) | Posted | Count of Participants | Participants | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days. |
|
|
|
| Secondary | Colectomy | Surgical Intervention - Colectomy | Posted | Count of Participants | Participants | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days. |
|
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D047028 |
| Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D013812 | Therapeutics |