MedTrace Logo

Effectiveness of Fecal Flora Alteration for Eradication of Carbapenemase-producing Enterobacteriaceae Colonization

NCT03802461 · Status: SUSPENDED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-11-03

No results posted yet for this study

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 25-50% of cases. Fecal microbiota transplantation (FMT) is the transfer of stool from a healthy donor to a recipient to alter the composition of gut microbes. Early studies support its use for eliminating CPE carriage but definitive studies are lacking. The investigators propose a feasibility pilot for a multicenter, non-blinded randomized trial comparing the effectiveness of FMT with no intervention (standard of care) in eliminating intestinal carriage of CPE. Forty patients with CPE will be randomly assigned to receive FMT by enema or no intervention. Feasibility will be demonstrated by the ability to recruit and retain 40 patients over 12 months, and to provide FMT made at a central site to at least one off-site hospital. The primary clinical endpoint for the full trial is CPE intestinal carriage 3 months after the intervention. Secondary endpoints include: CPE carriage at 1, 6 and 12 months; time to decolonization of CPE; safety; CPE infections over 12 months; and, intestinal carriage of other antibiotic-resistant organisms. Data on the clinical outcomes will be collected but not analyzed in this feasibility study.

Conditions

Interventions

BIOLOGICAL

Fecal Microbiota Transplantation (FMT)

Feces from healthy donor

Sponsors & Collaborators

  • Sinai Health System, Ontario, Canada

    collaborator UNKNOWN

  • University of Toronto, Ontario, Canada

    collaborator UNKNOWN

  • The Toronto Invasive Bacterial Diseases Network, Ontario, Canada

    collaborator UNKNOWN

  • Public Health Ontario Laboratories, Ontario, Canada

    collaborator UNKNOWN

  • Susy Hota

    lead OTHER

Principal Investigators

  • Susy S. Hota, MD MSc FRCPC · Infectious Diseases Physician, University Health Network

  • Susan M. Poutanen, MD MPH FRCPC · Microbiologist & Infectious Disease Physician, Sinai Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-22
Primary Completion
2023-12-15
Completion
2024-03-20

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03802461 on ClinicalTrials.gov