Clinical Effectiveness of Egg-derived Polyclonal Antibodies (IM-01) for the Treatment of Mild-moderate Clostridium Difficile Infection (CDI)

CP-IM-01-2017A

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.

2019-10-04

2023-12-30

2024-03-30

Recruiting

Early phase I

60

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 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Twenty four patients in each group will receive IM-01 treatment at 20g or 10g twice daily:for 10-14 days.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Patients will be randomized 1:1 to receive IM-01 treatment dosage at 20g or 10g twice a day'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2022-12-16