Treatment of Mild-moderate Clostridium Difficile Infection (CDI)
Canada60 participantsStarted 2019-10-04
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female, aged 18 to 89
* In good general health as evidenced by medical history or Diagnosed with specific condition/disease or Exhibits specific clinical signs or symptoms or physical/oral examination findings
* 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 received \< 24 h of SOC therapy for CDI.
* Participants presented with primary CDI episode or any number of CDI relapse recurrence of CDI
* Participants comply with the eligibility criteria and willing to participate in the study including the 8 week post treatment follow up period.
* White Blood Cell absolute neutrophil count \<15 x 109/L,
* Women of reproductive potential must use highly effective contraception. For those with child bearing potential, the following methods of birth control are required from Visit 1 up to at least 30 days after study treatment discontinuation: 1). Diaphragm, female condom or cervical cap, partner's use of a condom, any of which must be used in combination with a spermicide; 2). Intra-uterine device; 3). Oral or injectable contraceptive agen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine Clinical Response to IM-01 Treatment for CDI for 14 days
Timeframe: 10-14 days of IM-01 post-treatment
2
Reduce C. difficile pathogen count, spore count, and C. difficile Toxin Titers in stool samples following IM-01 treatment,