NCT03065374

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2017

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2019

Completed
Last Updated

December 26, 2019

Status Verified

September 1, 2019

Enrollment Period

2.2 years

First QC Date

February 14, 2017

Last Update Submit

December 24, 2019

Conditions

Clostridium Difficile InfectionClostridium Difficile Infection Recurrence

Outcome Measures

Primary Outcomes (2)

  • Adverse events incidence

    Number of adverse events

    12 weeks

  • Adverse events severity

    Severity of adverse events

    12 weeks

Secondary Outcomes (5)

  • Mortality rate

    0, 7, 14 days and 4, 8, 12 weeks

  • Disease symptoms incidence

    0, 7, 14 days and 4, 8, 12 weeks

  • Disease symptoms severity

    0, 7, 14 days and 4, 8, 12 weeks

  • Recurrence rate

    12 weeks

  • Recovery rate

    4, 12 weeks

Study Arms (2)

Treatment arm A

EXPERIMENTAL

IMM-529, 1000 mg three times daily, orally

Biological: IMM-529

Treatment arm B

PLACEBO COMPARATOR

Matching Placebo, three times daily, orally

Other: Placebo

Interventions

IMM-529BIOLOGICAL

IMM-529

Treatment arm A
PlaceboOTHER

Matching placebo

Treatment arm B

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hadassah Medical Center

Jerusalem, Israel

Location

Sheba Hospital

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Neta Tobis

    Immuron Limited

    STUDY CHAIR

  • Jerry Kanellos

    Immuron Limited

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 27, 2017

Study Start

September 1, 2017

Primary Completion

November 7, 2019

Study Completion

November 7, 2019

Last Updated

December 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)