Clostridium Difficile Infection RecurrencePhase 1NCT04891965
A Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)
A Phase 1 study testing ART24 in people with Clostridium Difficile Infection Recurrence, run by Adiso Therapeutics at 15 sites in 2 countries.
Trial summary
This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent C. difficile infection (CDI) who have completed a standard of care course of CDI antibiotics and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection Recurrence
- What is being tested?
- ART24
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 27 Feb 2020to 13 Oct 2022
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have successfully completed a full course of a standard of care CDI antibiotic for a qualifying CDI episode (primary or recurrent) within 3 to 7 days of randomization
- Qualifying CDI episode must meet all of the following (3) criteria
- Positive stool C. difficile toxin (NAAT, EIA, CCTA, or equivalent test) as documented by study site AND
- History of ≥3 unformed stools (Bristol scores of 5, 6, or 7) within 24 hours
- Received standard of care antibiotic treatment for CDI diagnosis
- Prior to the first dose of study drug, completion of standard of care antibiotic therapy with oral vancomycin, metronidazole, or fidaxomicin for CDI with a treatment duration of 10 to 21 days
- Clinical cure assessed at Day 1 visit (randomization) defined as ≤2 unformed stools per day for at least 2 consecutive days and maintained through Day 1 without the need for further antibiotic therapy
- Able to begin treatment with study drug within 3 to 7 days following completion (i.e., last dose) of the CDI antibiotic course for the qualifying CDI episode
Who cannot join
- Body mass index ≥40.0 kg/m2
- Life expectancy of ≤12 months
- Inpatient (in hospital or skilled nursing facility) at the time of randomization
- Current (i.e., qualifying) CDI episode required admission to an Intensive Care Unit
- Pregnant, breastfeeding, or seeking pregnancy while on study
- Have, as determined by the Investigator, a history or clinical/laboratory manifestations of significant neurological, renal, hepatic, hematologic, cardiac, pulmonary, metabolic, endocrine, psychiatric, GI disorders other than CDI (including infectious, ischemic, or immunological diseases), human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) infection, or other condition that could interfere with the evaluation of safety or efficacy, or put the subject at risk of harm from study participation
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- Have an active malignancy of any type or history of a malignancy within past 5 years, except for treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Have an acute febrile illness (fever >38°C [100.4°F]) at Day 1
- Drug, alcohol, or substance dependence within the last 2 years
- Any of the following laboratory results at Screening:
- White blood cell count ≥15,000 cells/mm3
- Absolute neutrophil count <1000/mm3
- Liver function test result (e.g., aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), or total bilirubin) of ≥3 times the upper limit of normal
- Serum albumin <3 g/dL
- Serum creatinine >1.8 mg/dL and oliguric
- Use of systemic antibiotic therapy for conditions other than CDI within 7 days of randomization or expectation to require antibiotic therapy for conditions other than CDI for 12 weeks following the first dose of study drug for Cohort A or 16 weeks following the first dose of study drug for Cohort B, including subtherapeutic doses of oral antibiotics (e.g., for rosacea)
- Have a known immunodeficiency disorder, including but not limited to:
- An immunodeficiency disease
- Receiving, or plans to receive, treatment with systemic corticosteroids equivalent to >10 mg prednisone per day
- Receiving, or plans to receive, myelosuppressive chemotherapy
- Previous fecal transplant or live biotherapeutic product within 1 year of randomization
- Treatment with bezlotoxumab (Zinplava™) for the qualifying CDI episode
- Diagnosis of inflammatory bowel disease (including but not limited to: Crohn's disease, ulcerative colitis, microscopic colitis)
- Active irritable bowel syndrome [those with diarrhea predominant or alternating constipation and diarrhea] (in past 6 months based on Rome IV criteria and subject deemed not suitable for study by Investigator's judgment)
- Celiac disease not well controlled on gluten-free diet
- Active gastroparesis, toxic megacolon, pseudomembranous colitis, colostomy, intestinal resection (except appendectomy), ileus or short gut syndrome
- History of chronic diarrhea apart from prior CDI
- Intra-abdominal surgery, including laparoscopic procedures, within 8 weeks of Screening (appendectomy and cholecystectomy excluded)
- History of difficulty swallowing food or liquids
- Taking antidiarrheal agents (e.g., loperamide) or laxatives (e.g., senna) on a regular basis
- Use of non-dietary probiotic supplements within 7 days of Day 1 or plan to use non-dietary probiotic supplements while on study through Week 12 in Cohort A and Week 16 in Cohort B
- Known to have consumed fermented or other foods that may contain B. amyloliquefaciens (such as miso, soybean paste, or fermented rice- or locust bean-derived products) within 7 days prior to Day 1, or plan to consume them prior to Week 12 for Cohort A and prior to Week 16 for Cohort B
- Participation in a clinical trial of an investigational drug or medical device within 30 days or 5 half-lives, whichever is longer, prior to the Screening visit
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States13 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Mercury Street Medical Group
Butte, Montana, 59701
Gastro Florida
Clearwater, Florida, 33765
Doral Medical Research
Doral, Florida, 33166
DiGiovanna Institute
Massapequa, New York, 11758
NYU Grossman School of Medicine
New York, New York, 10016
Weill Cornell Medicine
New York, New York, 10021
Palmtree Clinical Research
Palm Springs, California, 92262
Advanced Clinical Research
Riverton, Utah, 84065
Mayo Clinic
Rochester, Minnesota, 55905
Louisiana Research Center
Shreveport, Louisiana, 71105
Montefiore Medical Center
The Bronx, New York, 10467
Frontier Clinical Research, LLC
Uniontown, Pennsylvania, 15401
Canada2 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Intermed Groupe Sante
Chicoutimi, Quebec, G7H 7Y8
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Phase 1 Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)
This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent C. difficile infection (CDI) who have completed a standard of care course of CDI antibiotics and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily doses of ART24 or placebo. Subjects will be followed for 6 months after the last dose of study drug.
Read the detailed description
This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent CDI (primary [meaning the first occurrence they have had] or recurrent infection) who have completed a standard of care course of CDI antibiotics (vancomycin, fidaxomicin, or metronidazole administered for 10 to 21 days) and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily doses of ART24 or placebo. Subjects will be followed for 6 months after the last dose of study drug.
Subjects will receive study drug in the following 2 sequential cohorts:
- Cohort A: ART24 or placebo once daily for 7 days (8 subjects)
- Cohort B: ART24 or placebo once daily for 28 days (28 subjects)
In each cohort, subjects will be randomized in a ratio of 3 [active]:1 [placebo]. Subjects who are randomized to active treatment in both cohorts will receive ART24 (5×10^9 colony-forming units [CFU]) daily.
Initiation of Cohort B will only occur once the Data Review Committee (DRC) has evaluated blinded safety data (through Week 2) from Cohort A and recommends that the study proceed to the next cohort.
- Being tested
- ART24, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART24Biological
Also called ADS024
Each ART24 capsule will contain lyophilized ART24 and inactive excipients. ART24 will be supplied in a dose strength of 5×10^9 CFU/capsule. Subjects will receive 1 capsule daily.
PlaceboDrug
Each placebo capsule is identical in appearance, weight, and packaging to ART24 capsules, but will contain only the inactive excipients. Subjects will receive 1 capsule daily.
| Study group | Role | What they receive |
|---|---|---|
| ART24 (Cohort A) | Experimental | In Cohort A, subjects will receive ART24 or placebo daily for 7 days Receives: Biological: ART24 |
| Placebo (Cohort A) | Placebo comparator | In Cohort A, subjects will receive ART24 or placebo daily for 7 days Receives: Drug: Placebo |
| ART24 (Cohort B) | Experimental | In Cohort B, subjects will receive ART24 or placebo daily for 28 days Receives: Biological: ART24 |
| Placebo (Cohort B) | Placebo comparator | In Cohort B, subjects will receive ART24 or placebo daily for 28 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety and tolerability of ART24 based on the percentage of subjects experiencing treatment-emergent adverse events (TEAEs).
The percentage of subjects experiencing a TEAE will be summarized using the MedDRA system organ class and preferred term.
Measured: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
Assess the safety and tolerability of ART24 based on the number of subjects observed with a change from baseline in clinical laboratory tests, vital signs, physical examination.
The number of subjects with a change from baseline from normal to abnormal in clinical laboratory test results, vital signs, physical examination will be summarized.
Measured: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
Secondary outcomes (4)
Recurrence of CDI
Defined as ≥3 unformed stools (Bristol Scores of 5, 6, or 7) within 24 hours, AND positive stool testing for C. difficile toxin as documented by the central laboratory, AND the need for antibiotic retreatment for CDI diagnosis.
Measured: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
Time to CDI Recurrence
Evaluating the time to CDI recurrence (if applicable) relative to the administration of study medication
Measured: Through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
Hospitalization for CDI
Evaluating the proportion of subjects who are hospitalized due to a CDI recurrence
Measured: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
ART24-positive Fecal Samples
Proportion of subjects with ART24-positive fecal sample assessed at each study visit
Measured: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start27 Feb 2020
- Primary completion7 Jul 2022
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile Infection RecurrenceStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiso Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renu Gupta, MD, Study director, Adiso Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891965
- Sponsor's protocol ID
- ART24-1-001
- Status last verified
- Oct 2022
- First submitted
- 29 Apr 2021
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Phase 1 Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)
- ClinicalTrials.gov ID
- NCT04891965
- Acronym / sponsor ID
- ART24-1-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Adiso TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 19 May 2021 (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 is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent C. difficile infection (CDI) who have completed a standard of care course of CDI antibiotics and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily doses of ART24 or placebo. Subjects will be followed for 6 months after the last dose of study drug.
Detailed description
This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent CDI (primary [meaning the first occurrence they have had] or recurrent infection) who have completed a standard of care course of CDI antibiotics (vancomycin, fidaxomicin, or metronidazole administered for 10 to 21 days) and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily doses of ART24 or placebo. Subjects will be followed for 6 months after the last dose of study drug.
Subjects will receive study drug in the following 2 sequential cohorts:
- Cohort A: ART24 or placebo once daily for 7 days (8 subjects)
- Cohort B: ART24 or placebo once daily for 28 days (28 subjects)
In each cohort, subjects will be randomized in a ratio of 3 [active]:1 [placebo]. Subjects who are randomized to active treatment in both cohorts will receive ART24 (5×10^9 colony-forming units [CFU]) daily.
Initiation of Cohort B will only occur once the Data Review Committee (DRC) has evaluated blinded safety data (through Week 2) from Cohort A and recommends that the study proceed to the next cohort.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ART24 (Cohort A) | Experimental | Biological: ART24In Cohort A, subjects will receive ART24 or placebo daily for 7 days |
| Placebo (Cohort A) | Placebo comparator | Drug: PlaceboIn Cohort A, subjects will receive ART24 or placebo daily for 7 days |
| ART24 (Cohort B) | Experimental | Biological: ART24In Cohort B, subjects will receive ART24 or placebo daily for 28 days |
| Placebo (Cohort B) | Placebo comparator | Drug: PlaceboIn Cohort B, subjects will receive ART24 or placebo daily for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have successfully completed a full course of a standard of care CDI antibiotic for a qualifying CDI episode (primary or recurrent) within 3 to 7 days of randomization
- Prior to the first dose of study drug, completion of standard of care antibiotic therapy with oral vancomycin, metronidazole, or fidaxomicin for CDI with a treatment duration of 10 to 21 days
- Clinical cure assessed at Day 1 visit (randomization) defined as ≤2 unformed stools per day for at least 2 consecutive days and maintained through Day 1 without the need for further antibiotic therapy
- Able to begin treatment with study drug within 3 to 7 days following completion (i.e., last dose) of the CDI antibiotic course for the qualifying CDI episode
Key exclusion criteria (33 listed)
- Body mass index ≥40.0 kg/m2
- Life expectancy of ≤12 months
- Inpatient (in hospital or skilled nursing facility) at the time of randomization
- Current (i.e., qualifying) CDI episode required admission to an Intensive Care Unit
- Pregnant, breastfeeding, or seeking pregnancy while on study
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 |
|---|---|---|
| ART24Also: ADS024Each ART24 capsule will contain lyophilized ART24 and inactive excipients. ART24 will be supplied in a dose strength of 5×10^9 CFU/capsule. Subjects will receive 1 capsule daily. | Biological | ART24 (Cohort A), ART24 (Cohort B) |
| PlaceboEach placebo capsule is identical in appearance, weight, and packaging to ART24 capsules, but will contain only the inactive excipients. Subjects will receive 1 capsule daily. | Drug | Placebo (Cohort A), Placebo (Cohort B) |
Primary outcome
Assess the safety and tolerability of ART24 based on the percentage of subjects experiencing treatment-emergent adverse events (TEAEs).
Time frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
The percentage of subjects experiencing a TEAE will be summarized using the MedDRA system organ class and preferred term.
Assess the safety and tolerability of ART24 based on the number of subjects observed with a change from baseline in clinical laboratory tests, vital signs, physical examination.
Time frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
The number of subjects with a change from baseline from normal to abnormal in clinical laboratory test results, vital signs, physical examination will be summarized.
4 secondary outcomes
Recurrence of CDI
Time frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
Time to CDI Recurrence
Time frame: Through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
Hospitalization for CDI
Time frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
ART24-positive Fecal Samples
Time frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- 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.
Renu Gupta, MD study director
Adiso Therapeutics, Inc.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ART24 in people with Clostridium Difficile Infection Recurrence, run by Adiso Therapeutics at 15 sites in 2 countries.
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 8 inclusion and 33 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: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the safety and tolerability of ART24 based on the percentage of subjects experiencing treatment-emergent adverse events (TEAEs). (time frame: Randomization through the week 12 study visit (Cohort A) or week 16 study visit (Cohort B)). 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 17 Oct 2022.