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Treatment for Clostridium-difficile Infection With IMM529

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. Identifier: NCT03065374
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : July 12, 2018
Information provided by (Responsible Party):
Immuron Ltd.

Brief Summary:
This study will evaluate the safety and tolerability of IMM-529 together with standard of care (SOC) in patients with Clostridium-difficile Infection.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Clostridium Difficile Infection Recurrence Biological: IMM-529 Other: Placebo Phase 1 Phase 2

Detailed Description:

Subjects who provide voluntary written informed consent will be screened for eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate.

Eligible subjects will be randomized up to 3 weeks post diagnosis of Clostridium-difficile Infection given SOC initiated already.

Each subject will return to the study clinic for assessment and required study procedures on Day 7, Day 14, Week 4, Week 8 and Week 12 post randomization. Treatment duration will be 28 days and follow up will last up to 12 weeks post randomization.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I/II, Randomized, Double Blind, Placebo-controlled Clinical Study of IMM529 for the Treatment of Clostridium-difficile Infection (CDI).
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Treatment arm A
IMM-529, 1000 mg three times daily, orally
Biological: IMM-529

Placebo Comparator: Treatment arm B
Matching Placebo, three times daily, orally
Other: Placebo
Matching placebo

Primary Outcome Measures :
  1. Adverse events incidence [ Time Frame: 12 weeks ]
    Number of adverse events

  2. Adverse events severity [ Time Frame: 12 weeks ]
    Severity of adverse events

Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: 0, 7, 14 days and 4, 8, 12 weeks ]
    Mortality rate

  2. Disease symptoms incidence [ Time Frame: 0, 7, 14 days and 4, 8, 12 weeks ]
    Time to resolution of symptoms defined by cessation of unformed stools

  3. Disease symptoms severity [ Time Frame: 0, 7, 14 days and 4, 8, 12 weeks ]
    Number of unformed stools per day

  4. Recurrence rate [ Time Frame: 12 weeks ]
    Rate of subjects with recurring symptoms and positive stool test for C-Diff

  5. Recovery rate [ Time Frame: 4, 12 weeks ]
    Stool sampling - neutralizing antibodies and spores and IMM-529 recovery rate

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Unformed stools (≥3 loose stools in 24 hours at diagnosis)
  3. Positive stool testing for C. difficile: PCR and Toxin B positive; or PCR and GDH positive.
  4. Up to 3 weeks of diagnosis with at least 20 subjects within 72 hours of diagnosis
  5. Patient or legal representative must have read, understood, and provided written informed consent after the nature of the study has been fully explained.

Exclusion Criteria:

  1. History of chronic diarrheal illness such as ulcerative colitis or Crohn's disease
  2. Known concurrent severe organ insufficiency:

    Liver: Decompensated cirrhosis (Any complication of cirrhosis or Child Score ≥7).

    Cardiovascular: New York Heart Association (NYHA) class IV heart failure, or Ejection fraction <30%.

    Respiratory: Severe exercise restriction (ie, unable to climb stairs or perform household duties); chronic hypoxia, hypercapnia, severe pulmonary hypertension (>40 mmHg); or respirator dependency Renal: Receiving chronic dialysis or GFR < 15 mL/min/1.73m2

  3. Other etiology of diarrhea.
  4. Fulminant CDI, as defined by any of the following attributable to CDI:

    1. Hypotension (Mean arterial pressure < 65mmHg)
    2. Ileus or significant abdominal distention
    3. Toxic megacolon
    4. End organ damage/failure:

    Respiratory - Need for mechanical ventilation. Cardiac - Pulmonary edema. Renal - Serum creatinine increase >3x Baseline, GFR decrease >50%, urinary output <0.5mL/kg/hr > 12hrs. Hepatic - Liver failure (INR>1.5, Hepatic encephalopathy), decompensation of cirrhosis, bilirubin > 2.5mg/dL.

  5. Severe Clostridium difficile colitis with imminent surgery planned in less than 24 hours.
  6. Immunocompromise due to: immunosuppressants, chemotherapy, radiation in the last 3 months, long-term steroids (>10mg >3 months) or high-dose steroids (>40mg > 3 weeks), leukemia or lymphoma in the last 5 years, or HIV.
  7. Any active malignancy within the last 5 years apart from localized skin cancer (squamous cell carcinoma or basal cell carcinoma) that was fully excised.
  8. Positive pregnancy test within 24 hours of study infusion or an unwillingness to undergo pregnancy testing in females of child-bearing potential. Females capable of child-bearing must agree not to become pregnant from the time of study enrollment until at least 28 days after completion of study treatment period. If a woman is sexually active and has no history of hysterectomy or tubal ligation, she must agree to use 2 acceptable contraceptives (see section 7.4.1.) while participating in the study and for 28 days following the last dose of study drug.
  9. Breastfeeding
  10. Receipt of other investigational study agent within previous 30 days.
  11. Cow milk allergy, lactose intolerance or any known or suspected hypersensitivity to study products
  12. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the patient participating in the study or make it unlikely the patient could complete the study.

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 identifier (NCT number): NCT03065374

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Contact: Yoseph Caraco Dr., MD 972-2-6779398

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Hadassah Medical Center Recruiting
Jerusalem, Israel
Contact: Yoseph Caraco, MD    +972-2-6779398   
Principal Investigator: Yoseph Caraco, MD         
Sheba Hospital Not yet recruiting
Tel HaShomer, Israel
Contact: Galia Rahav, MD    +972-3-5303500   
Principal Investigator: Galia Rahav, MD         
Sponsors and Collaborators
Immuron Ltd.
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Study Chair: Neta Tobis Immuron Limited
Study Chair: Jerry Kanellos Immuron Limited

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Responsible Party: Immuron Ltd. Identifier: NCT03065374     History of Changes
Other Study ID Numbers: IMM592-EP1206
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: May 2018
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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Communicable Diseases
Clostridium Infections
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections