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Treatment for Clostridium-difficile Infection With IMM529

Primary Purpose

Clostridium Difficile Infection, Clostridium Difficile Infection Recurrence

Status
Terminated
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
IMM-529
Placebo
Sponsored by
Immuron Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical Center
  • Sheba Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment arm A

Treatment arm B

Arm Description

IMM-529, 1000 mg three times daily, orally

Matching Placebo, three times daily, orally

Outcomes

Primary Outcome Measures

Adverse events incidence
Number of adverse events
Adverse events severity
Severity of adverse events

Secondary Outcome Measures

Mortality rate
Mortality rate
Disease symptoms incidence
Time to resolution of symptoms defined by cessation of unformed stools
Disease symptoms severity
Number of unformed stools per day
Recurrence rate
Rate of subjects with recurring symptoms and positive stool test for C-Diff
Recovery rate
Stool sampling - neutralizing antibodies and spores and IMM-529 recovery rate

Full Information

First Posted
February 14, 2017
Last Updated
December 24, 2019
Sponsor
Immuron Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03065374
Brief Title
Treatment for Clostridium-difficile Infection With IMM529
Official Title
A Phase I/II, Randomized, Double Blind, Placebo-controlled Clinical Study of IMM529 for the Treatment of Clostridium-difficile Infection (CDI).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped due to slow recruitment. All subjects completed their participation including follow up period per protocol. No safety issues.
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 7, 2019 (Actual)
Study Completion Date
November 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immuron Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection, Clostridium Difficile Infection Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm A
Arm Type
Experimental
Arm Description
IMM-529, 1000 mg three times daily, orally
Arm Title
Treatment arm B
Arm Type
Placebo Comparator
Arm Description
Matching Placebo, three times daily, orally
Intervention Type
Biological
Intervention Name(s)
IMM-529
Intervention Description
IMM-529
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Adverse events incidence
Description
Number of adverse events
Time Frame
12 weeks
Title
Adverse events severity
Description
Severity of adverse events
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mortality rate
Description
Mortality rate
Time Frame
0, 7, 14 days and 4, 8, 12 weeks
Title
Disease symptoms incidence
Description
Time to resolution of symptoms defined by cessation of unformed stools
Time Frame
0, 7, 14 days and 4, 8, 12 weeks
Title
Disease symptoms severity
Description
Number of unformed stools per day
Time Frame
0, 7, 14 days and 4, 8, 12 weeks
Title
Recurrence rate
Description
Rate of subjects with recurring symptoms and positive stool test for C-Diff
Time Frame
12 weeks
Title
Recovery rate
Description
Stool sampling - neutralizing antibodies and spores and IMM-529 recovery rate
Time Frame
4, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Unformed stools (≥3 loose stools in 24 hours at diagnosis) Positive stool testing for C. difficile: PCR and Toxin B positive; or PCR and GDH positive. Up to 3 weeks of diagnosis with at least 20 subjects within 72 hours of diagnosis 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: History of chronic diarrheal illness such as ulcerative colitis or Crohn's disease 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 Other etiology of diarrhea. Fulminant CDI, as defined by any of the following attributable to CDI: Hypotension (Mean arterial pressure < 65mmHg) Ileus or significant abdominal distention Toxic megacolon 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. Severe Clostridium difficile colitis with imminent surgery planned in less than 24 hours. 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. Any active malignancy within the last 5 years apart from localized skin cancer (squamous cell carcinoma or basal cell carcinoma) that was fully excised. 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. Breastfeeding Receipt of other investigational study agent within previous 30 days. Cow milk allergy, lactose intolerance or any known or suspected hypersensitivity to study products 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neta Tobis
Organizational Affiliation
Immuron Limited
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jerry Kanellos
Organizational Affiliation
Immuron Limited
Official's Role
Study Chair
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
Sheba Hospital
City
Tel HaShomer
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment for Clostridium-difficile Infection With IMM529

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