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Treatment of Mild-moderate Clostridium Difficile Infection (CDI)

NCT04121169 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-12-16

No results posted yet for this study

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.

Conditions

  • Clostridium Difficile Infection (CDI)

Interventions

DRUG

IM-01

Antibodies react with C. difficile toxin, C. difficile bacteria and spores; neutralizes the toxin and inhibit the growth of spores and vegetative forms of C. difficile

Sponsors & Collaborators

  • University of Calgary

    collaborator OTHER

  • University of Manitoba

    collaborator OTHER

  • ImmuniMed Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas J Louie, MD,FRCPC · University of Calgary Foothills Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-04
Primary Completion
2023-12-30
Completion
2024-03-30

Countries

  • Canada

Study Locations

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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 NCT04121169 on ClinicalTrials.gov