Status:
UNKNOWN
Treatment of Mild-moderate Clostridium Difficile Infection (CDI)
Lead Sponsor:
ImmuniMed Inc.
Collaborating Sponsors:
University of Calgary
University of Manitoba
Conditions:
Clostridium Difficile Infection (CDI)
Eligibility:
All Genders
18-89 years
Phase:
PHASE2
Brief 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. Re...
Detailed Description
INTRODUCTION: BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE The increased incidence of antibiotic resistant 'superbugs' has amplified the use of broad spectrum antibiotics worldwide. An unintended c...
Eligibility Criteria
Inclusion
- 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 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
- 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.
Key Trial Info
Start Date :
October 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04121169
Start Date
October 4 2019
End Date
March 30 2024
Last Update
December 16 2022
Active Locations (1)
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1
Foothills Medical Center
Calgary, Alberta, Canada, T2N 2T9