Treatment for Clostridium-difficile Infection With IMM529

Clostridium Difficile Infection Clinical Trial

Official title:

A Phase I/II, Randomized, Double Blind, Placebo-controlled Clinical Study of IMM529 for the Treatment of Clostridium-difficile Infection (CDI).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03065374
• Other study ID #: IMM592-EP1206
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 1, 2017
• Est. completion date: November 7, 2019

Study information

• Verified date: September 2019
• Source: Immuron Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 7, 2019
• Est. primary completion date: November 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Difficile Infection Recurrence
• Clostridium Infections
• Communicable Diseases
• Infection
• Recurrence

Intervention

Biological:
• IMM-529
IMM-529

Other:
• Placebo
Matching placebo

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem
Israel	Sheba Hospital	Tel HaShomer

Sponsors (1)

Lead Sponsor	Collaborator
Immuron Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events incidence	Number of adverse events	12 weeks
Primary	Adverse events severity	Severity of adverse events	12 weeks
Secondary	Mortality rate	Mortality rate	0, 7, 14 days and 4, 8, 12 weeks
Secondary	Disease symptoms incidence	Time to resolution of symptoms defined by cessation of unformed stools	0, 7, 14 days and 4, 8, 12 weeks
Secondary	Disease symptoms severity	Number of unformed stools per day	0, 7, 14 days and 4, 8, 12 weeks
Secondary	Recurrence rate	Rate of subjects with recurring symptoms and positive stool test for C-Diff	12 weeks
Secondary	Recovery rate	Stool sampling - neutralizing antibodies and spores and IMM-529 recovery rate	4, 12 weeks