Status:
SUSPENDED
Effectiveness of Fecal Flora Alteration for Eradication of Carbapenemase-producing Enterobacteriaceae Colonization
Lead Sponsor:
Susy Hota
Collaborating Sponsors:
Sinai Health System, Ontario, Canada
University of Toronto, Ontario, Canada
Conditions:
Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Carbapenemase-producing Enterobacteriaceae (CPE) are bacteria carried in the gastrointestinal tract that are resistant to carbapenems, antibiotics of last resort. CPE infections result in death in 25-...
Detailed Description
This is a multisite, open-label randomized controlled internal pilot trial designed to assess the feasibility of a larger trial aimed at determining the effectiveness of fecal microbiota transplantati...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- ≥ 1 rectal swab, groin, stool, or urine specimen positive for a CPE within the past 1 month.
- • Presence of CPE will be confirmed at baseline through collection of pooled groin/rectal swab and urine specimen.
- Women of childbearing age must be using at least one reliable form of birth control.
- Must be able to provide informed consent.
Exclusion
- Active infection with CPE at the time of assessment.
- Pregnancy, planned pregnancy or breastfeeding.
- Current admission to intensive care unit.
- Significantly immunocompromised patients .
- neutropenia (ANC \< 1)
- ongoing use of systemic corticosteroids \> 30 mg/day
- ongoing use of biologic therapy
- undergoing chemotherapy, received chemotherapy ≤ 30 days from baseline visit, or expected to undergo chemotherapy in the upcoming 12 months
- active hematologic malignancy
- solid organ transplant recipient
- hematopoetic stem cell transplant recipient
- HIV positive patients with cluster differentiation 4 (CD4) cell count \< 350
- Patients with ascites or receiving peritoneal dialysis.
- History of inflammatory bowel disease (Crohn's or Ulcerative colitis).
- Chronic diarrhea or active colitis for any reason.
- Ileus or active gastrointestinal motility disorder at baseline.
- History of total colectomy.
- Severe, irreversible bleeding disorder.
- History of anaphylactic or anaphylactoid allergic reaction to any foods.
- Anticipated life expectancy less than 6 months.
- Unable to tolerate enema.
- Participant is not a Canadian citizen or permanent resident, and not expected to remain in Toronto region for 12 months.
- Any reason in the view of the investigator.
Key Trial Info
Start Date :
March 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03802461
Start Date
March 22 2019
End Date
March 20 2024
Last Update
November 3 2022
Active Locations (13)
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1
William Osler Health System
Brampton, Ontario, Canada, L6R 3J7
2
Joseph Brant Hospital
Burlington, Ontario, Canada, L7S 1W7
3
Lakeridge Health
Oshawa, Ontario, Canada, L1G 2B9
4
MacKenzie Health
Richmond Hill, Ontario, Canada, L4C 4Z3