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Treatment of Mild-moderate Clostridium Difficile Infection (CDI) (IM-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04121169
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
University of Calgary
University of Manitoba
Information provided by (Responsible Party):
ImmuniMed Inc.

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. 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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection (CDI) Drug: IM-01 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Twenty four patients in each group will receive IM-01 treatment at 20g or 10g or 5g twice daily:for 10-14 days.
Masking: None (Open Label)
Masking Description: Patients will be randomized 1:1:1 to receive IM-01 treatment dosage at 20g or 10g or 5g twice a day
Primary Purpose: Treatment
Official Title: Clinical Effectiveness of Egg-derived Polyclonal Antibodies (IM-01) for the Treatment of Mild-moderate Clostridium Difficile Infection (CDI)
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Adults subjects with CDI receiving 10g a day
5 g twice a day for 10 - 14 days
Drug: IM-01
Antibodies react with C. difficile toxin, C. difficile bacteria and spores; neutralizes the toxin and inhibit the growth of spores and vegetative forms of C. difficile
Other Name: Chicken egg-derived anti-C.difficile polyclonal antibodies

Adults subjects with CDI receiving 20g a day
10 g twice a day for 10 - 14 days
Drug: IM-01
Antibodies react with C. difficile toxin, C. difficile bacteria and spores; neutralizes the toxin and inhibit the growth of spores and vegetative forms of C. difficile
Other Name: Chicken egg-derived anti-C.difficile polyclonal antibodies

Adults subjects with CDI receiving 40 g a day
20 g twice a day for 10 - 14 days
Drug: IM-01
Antibodies react with C. difficile toxin, C. difficile bacteria and spores; neutralizes the toxin and inhibit the growth of spores and vegetative forms of C. difficile
Other Name: Chicken egg-derived anti-C.difficile polyclonal antibodies




Primary Outcome Measures :
  1. Determine Clinical Response to IM-01 Treatment for CDI for 14 days [ Time Frame: 10-14 days of IM-01 post-treatment ]
    Decrease the frequency of unformed bowel motions to less than 3 per day and sustain for the duration of treatment to 10-14 days.

  2. Reduce C. difficile pathogen count, spore count, and C. difficile Toxin Titers in stool samples following IM-01 treatment, [ Time Frame: day 56 IM-01 post-treatment ]
    To enumerate numbers of C.difficile present per g of stool by dilution at plate counts on CCFA or Biomerieux C. difficile Chrom Agar , Total counts on three plates express as log 10 count /g versus spore counts after alcohol shock. Toxin titers: expressed as 1/dilution of the fecale filtrate neutralized by specific anti-toxin antibodies from Tech Lab using the CCNA test. .


Secondary Outcome Measures :
  1. Rate of recurrence of CDI in day 44, day 56 and day 70 IM-01 post-treatment follow up period [ Time Frame: day 44, 56 and 70 post- IM-01 treatment ]

    In those that responded to treatment with resolution of CDI, the rate of recurrence of CDI in a 30, 42 and 56 day follow up period.

    • Exploratory outcome: patterns of C. difficile microbial counts and toxin titres in relationship to clinical outcomes from treatment assignments




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male or Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121169


Contacts
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Contact: Pradip K Maiti, M.Sc, Ph.D. 204-997-0398 dr.pmaiti@nutratechglobal.com

Locations
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Canada, Alberta
Foothills Medical Center Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Thomas J Louie, MD, FRCPC    403-944-2038    thomas.louie@ahs.ca   
Sub-Investigator: Gregory Hammond, MD,CM,FRCP         
Sub-Investigator: Terrance Wuerz, MD,FRCPC         
Sponsors and Collaborators
ImmuniMed Inc.
University of Calgary
University of Manitoba
Investigators
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Principal Investigator: Thomas J Louie, MD,FRCPC University of Calgary Foothills Medical Center

Publications of Results:
LITERATURE REFERENCES 1. Halsey J. Am. J. Health-Syst Pharm 65: 705-715, 2008. 2. Lessa, F.C et al. N.Eng.J.Med.372: 825-834, 2015. 3. Kee, V. R. Amer. J. Geriatric Pharmacotherapy. 10: 14-24, 2012 4. Centers for Disease Control and Prevention. Vital signs: Making healthcare safer. Stopping C. difficile infections. http:/www.cdc.gov/vitalsigns/Hai/StoppingC.difficile/. March, 2012 5. Comparison of the burdens of hospital-onset, healthcare facility-associated Clostridium difficile Infection and of healthcare-associated infection due to methicillin-resistant Staphylococcus aureus in community hospitals. Miller B.A. et al. Infect Control Hosp Epidemiol. 32:387-390, 2011. 6. (APIC) National Prevalence study for Clostridium difficile in US Healthcare Facilities. November 11, 2008. 7. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): treatment guidance document for Clostridium difficile infection (CDI). Bauer , M.P.; Kuijper, E.J. van Dissel, I.T;. Clin. Microbiol. Infect. 2009, 15: 1067-79. 8. Society for Healthcare Epidemiology of America; Infectious Disease Society of America Clinical Practice guidelines for Clostridium difficile infection in adults: 2010 updates by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Disease Society of America (IDSA). Cohen S.F.; Gerding, D.N.; Johnson, S; et al. Infect. Control Hosp. Epidemiol. 2010, 31: 431-55. 9. Treatment of First recurrence of Clostridium difficile Infection Fidaxomicin Versus Vancomycin. Cornely, O.A; Miller, M.A; Louie, T.J. et al. Clin. Infect. Dis. 2012, 55 (Suppl 2) S154-61. 10. Fidaxomycin versus Vancomycin for C. difficile infections. Louie, T.J; Miller, M.A.; Mullane. D.O et al. New Eng. J. Med. 2011, 364: 422031. 11. Consequence of Clostridium difficile infection: Understanding of healthcare burden. Bouza E. Clin. Microbiol. Infect. 18 (suppl 6) 5-12, Dec 2012. 12. Emergence and global spread of epidemic healthcare-associated Clostridium difficile. He M, Miyajima F, Roberts P et al. Nat. Genet. 45: 109-113, 2012. 13. PCR ribotyping and antimicrobial susceptibility testing of isolates of Clostridium difficile cultured from toxin-positive diarrheal stools of patients receiving medical care in Canadian hospitals: the Canadian Clostridium difficile Surveillance Study (CAN-DIFF) 2013-2015. Karlowsky J. A et al. Diag. Microbiol and Infect Dis. Vol 91. Pages 105-111, 2018 . 14. Antibodies for Treatment of Clostridium difficile Infections. Humphreys, D.P. and Wilcox, M.H. Clinical and Vaccine Immunology 21: 913-923, 2014. 15. Association between antibody response to toxin A and protection against recurrent C. difficile diarrhea. Kyne l et al. Lancet 357: 189-193, 2001. 16. IgG Antibody Response to Toxin A and Toxin B in patients with Clostridium difficile Infection. Wullt M et al. Clin. Vaccine Immunol. 19; 1552-54, 2012. Protocol CP-IM-01-2017A 10 July 2018 (Version 5) ________________________________________________________________________________________________________

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Responsible Party: ImmuniMed Inc.
ClinicalTrials.gov Identifier: NCT04121169    
Other Study ID Numbers: CP-IM-01-2017A
HC6-024-C218566 ( Other Identifier: Health Canada- Biological and Genetic Therapies Directorate )
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs