Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-24 @ 12:00 PM
NCT ID:
NCT03802461
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. ≥ 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.
3. Women of childbearing age must be using at least one reliable form of birth control.
4. Must be able to provide informed consent.
Exclusion Criteria:
1. Active infection with CPE at the time of assessment.
2. Pregnancy, planned pregnancy or breastfeeding.
3. Current admission to intensive care unit.
4. 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
5. Patients with ascites or receiving peritoneal dialysis.
6. History of inflammatory bowel disease (Crohn's or Ulcerative colitis).
7. Chronic diarrhea or active colitis for any reason.
8. Ileus or active gastrointestinal motility disorder at baseline.
9. History of total colectomy.
10. Severe, irreversible bleeding disorder.
11. History of anaphylactic or anaphylactoid allergic reaction to any foods.
12. Anticipated life expectancy less than 6 months.
13. Unable to tolerate enema.
14. Participant is not a Canadian citizen or permanent resident, and not expected to remain in Toronto region for 12 months.
15. Any reason in the view of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03802461
Study Brief:
Protocol Section:
NCT03802461