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Polyclonal Antibodies

IM-01 for Clostridium Difficile Infection (IM-01 Trial)

Phase 2

Recruiting

Led By Thomas J Louie, MD,FRCPC

Research Sponsored by ImmuniMed Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has a diagnosis of CDI defined as (i) presence of diarrhea with 4 or more unformed stools within 24 hours and (ii) positive test for toxigenic C. difficile from stools collected within 7 days

Participants presented with primary CDI episode or any number of CDI relapse recurrence of CDI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 44, 56 and 70 post- im-01 treatment

Awards & highlights

IM-01 Trial Summary

This trial is testing whether or not IM-01, a egg-derived anti-C. difficile polyclonal antibody, is an effective treatment for CDI. Patients will be given increasing dosages of IM-01, twice daily, for 10-14 days and then followed for recurrence of CDI. If IM-01 is not effective, patients will be treated with standard of care CDI antibiotics.

Who is the study for?

This trial is for adults aged 18-89 with mild to moderate Clostridium Difficile Infection, experiencing diarrhea but not severe symptoms like high fever or extreme abdominal pain. Participants must be in good health or have specific conditions and agree to use effective contraception if of childbearing potential.Check my eligibility

What is being tested?

The study tests IM-01, an egg-derived antibody treatment for CDI. Patients will take varying doses twice daily for up to two weeks, monitoring symptom resolution and fecal tests. Non-responders get standard antibiotics instead.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions related to the immune system due to the introduction of antibodies, as well as any common issues associated with gastrointestinal treatments.

IM-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with C. difficile infection, confirmed by a stool test.

Select...

I have had at least one episode of C. diff infection.

IM-01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 44, 56 and 70 post- im-01 treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 44, 56 and 70 post- im-01 treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 44, 56 and 70 post- im-01 treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine Clinical Response to IM-01 Treatment for CDI for 14 days

Reduce C. difficile pathogen count, spore count, and C. difficile Toxin Titers in stool samples following IM-01 treatment

Secondary outcome measures

Rate of recurrence of CDI in day 44, day 56 and day 70 IM-01 post-treatment follow up period

IM-01 Trial Design

2Treatment groups

Experimental Treatment

Group I: Adults subjects with CDI receiving 40 g a dayExperimental Treatment1 Intervention

20 g twice a day for 10 - 14 days

Group II: Adults subjects with CDI receiving 20g a dayExperimental Treatment1 Intervention

10 g twice a day for 10 - 14 days

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryOTHER

792 Previous Clinical Trials

869,094 Total Patients Enrolled

ImmuniMed Inc.Lead Sponsor

University of ManitobaOTHER

595 Previous Clinical Trials

199,421 Total Patients Enrolled

Media Library

IM-01 (Polyclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04121169 — Phase 2

Clostridium Difficile Infection Research Study Groups: Adults subjects with CDI receiving 40 g a day, Adults subjects with CDI receiving 20g a day

Clostridium Difficile Infection Clinical Trial 2023: IM-01 Highlights & Side Effects. Trial Name: NCT04121169 — Phase 2

IM-01 (Polyclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04121169 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals can participate in this clinical investigation?

"Affirmative, the clinicaltrial.gov entry for this medical study attests to its ongoing recruitment process. It was first posted on October 4th 2019 and most recently updated on December 14th 2022, seeking 60 individuals at a single location."

Answered by AI

Is recruitment currently ongoing for this trial?

"We can confirm that this clinical trial is presently recruiting participants. The information was first uploaded to the website on October 4th 2019 and has since been amended as of December 14th 2022."

Answered by AI

What safety measures are in place for those undergoing this procedure?

"As this is Phase 2 trial, the safety of the proposed intervention has been assessed as a '2' since there are indications that it can be tolerated but no proof of efficacy."

Answered by AI

Is it feasible for me to join the clinical trial?

"This research trial is searching for 60 qualified individuals, aged between 18 and 89, who have been diagnosed with clostridium difficile infection. In addition to this prerequisite, participants must also be medically assessed as being in good health or exhibiting certain symptomatic attributes or physical findings."

Answered by AI