Overview

Treatment of Mild-moderate Clostridium Difficile Infection (CDI)

Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
Patients diagnosed to have mild-moderate CDI will be randomized to receive IM-01 egg-derived anti-C. difficile polyclonal antibodies in increasing dosages, twice daily, for a total of 10 - 14 days. Resolution of diarrhea and other symptoms and fecal test parameters will be used to assess clinical effectiveness of Immunotherapy with IM-01 antibodies. Patients will be followed for recurrence of CDI. Subjects who are assessed as non-respondents to IM-01 will be reassessed and treated with standard of care CDI antibiotics for 10 -14 days.
Phase:
Phase 2
Details
Lead Sponsor:
ImmuniMed Inc.
Collaborators:
University of Calgary
University of Manitoba
Treatments:
Antibodies
Immunoglobulins