Treatment of Mild-moderate Clostridium Difficile Infection (CDI)

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmuniMed Inc.
• Collaborators: University of Calgary; University of Manitoba
• Treatments: Antibodies; Immunoglobulins

Criteria

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 first 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 agent, implant, or transdermal contraceptive hormone patches. If a hormonal contraceptive is used, it must have been taken for at least one month prior to enrolment/randomization; 4). Sterilization method (tubal ligation/occlusion, or partner's vasectomy); 5). True abstinence from intercourse with a male partner only when this is in line with the preferred lifestyle of the subject.

• Men of reproductive potential must use condoms-

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

• known allergic reactions to chicken egg components.

• Female of child bearing potential and not receiving contraception; pregnant or lactating persons.

• severe CDI defined as >10 unformed bowel movements (UBMs)/24 h period, fever >38.5 o C, White Blood Cell count > 15 x 109/L, abdominal pain and tenderness on physical examination, toxic megacolon, ileus, nausea, vomiting.

• receipt of > 24 h of SOC treatment of CDI, or fecal microbial transplant (FMT) prior to enrollment.

• treatment with another investigational drug or other intervention within 30 days prior to enrollment including intravenous immunoglobulin (IVIG) or monoclonal intravenous (IV) antibody.

• received vaccine for C. difficile.

• concurrent use of probiotics of any type during treatment and follow up.

• unable to discontinue use of opiates for diarrhea control.

• co-infection with another gastrointestinal (GI) pathogen.

• presence of Inflammatory Bowel Disease (IBS), IBS with diarrhea (IBS-D), chronic diarrhea of unknown cause.

• any condition that hinders oral consumption. Exception: nasogastric tubes can be used to administer the product.

• death likely within study interval.

• any circumstance or medical condition under the Investigator's opinion that precludes participation.