Clostridium Difficile InfectionPhase 1/2NCT03065374
Treatment for Clostridium-difficile Infection With IMM529
A Phase 1/2 study testing IMM-529 in people with Clostridium Difficile Infection and Clostridium Difficile Infection Recurrence, run by Immuron Ltd. at 2 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Clostridium Difficile Infection, Clostridium Difficile Infection Recurrence
- What is being tested?
- IMM-529
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Sep 2017to 7 Nov 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase I/II, Randomized, Double Blind, Placebo-controlled Clinical Study of IMM529 for the Treatment of Clostridium-difficile Infection (CDI).
This study will evaluate the safety and tolerability of IMM-529 together with standard of care (SOC) in patients with Clostridium-difficile Infection.
Read the 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.
- Being tested
- IMM-529, Placebo
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM-529Biological
IMM-529
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm A | Experimental | IMM-529, 1000 mg three times daily, orally Receives: Biological: IMM-529 |
| Treatment arm B | Placebo comparator | Matching Placebo, three times daily, orally Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events incidence
Number of adverse events
Measured: 12 weeks
Adverse events severity
Severity of adverse events
Measured: 12 weeks
Secondary outcomes (5)
Mortality rate
Mortality rate
Measured: 0, 7, 14 days and 4, 8, 12 weeks
Disease symptoms incidence
Time to resolution of symptoms defined by cessation of unformed stools
Measured: 0, 7, 14 days and 4, 8, 12 weeks
Disease symptoms severity
Number of unformed stools per day
Measured: 0, 7, 14 days and 4, 8, 12 weeks
Recurrence rate
Rate of subjects with recurring symptoms and positive stool test for C-Diff
Measured: 12 weeks
Recovery rate
Stool sampling - neutralizing antibodies and spores and IMM-529 recovery rate
Measured: 4, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start1 Sep 2017
- Primary completion7 Nov 2019
- Study completion7 Nov 2019
Why it stopped: Study was stopped due to slow recruitment. All subjects completed their participation including follow up period per protocol. No safety issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immuron Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neta Tobis, Study chair, Immuron LimitedJerry Kanellos, Study chair, Immuron Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065374
- Sponsor's protocol ID
- IMM592-EP1206
- Status last verified
- Sep 2019
- First submitted
- 14 Feb 2017
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Double Blind, Placebo-controlled Clinical Study of IMM529 for the Treatment of Clostridium-difficile Infection (CDI).
- ClinicalTrials.gov ID
- NCT03065374
- Acronym / sponsor ID
- IMM592-EP1206
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to slow recruitment. All subjects completed their participation including follow up period per protocol. No safety issues.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Immuron Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 7 Nov 2019 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm A | Experimental | Biological: IMM-529IMM-529, 1000 mg three times daily, orally |
| Treatment arm B | Placebo comparator | Other: PlaceboMatching Placebo, three times daily, orally |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMM-529IMM-529 | Biological | Treatment arm A |
| PlaceboMatching placebo | Other | Treatment arm B |
Primary outcome
Adverse events incidence
Time frame: 12 weeks
Number of adverse events
Adverse events severity
Time frame: 12 weeks
Severity of adverse events
5 secondary outcomes
Mortality rate
Time frame: 0, 7, 14 days and 4, 8, 12 weeks
Disease symptoms incidence
Time frame: 0, 7, 14 days and 4, 8, 12 weeks
Disease symptoms severity
Time frame: 0, 7, 14 days and 4, 8, 12 weeks
Recurrence rate
Time frame: 12 weeks
Recovery rate
Time frame: 4, 12 weeks
Results and safety
The study was stopped early (reason given: Study was stopped due to slow recruitment. All subjects completed their participation including follow up period per protocol. No safety issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neta Tobis study chair
Immuron Limited
Jerry Kanellos study chair
Immuron Limited
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMM-529 in people with Clostridium Difficile Infection and Clostridium Difficile Infection Recurrence, run by Immuron Ltd. at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was stopped due to slow recruitment. All subjects completed their participation including follow up period per protocol. No safety issues.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events incidence (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.