Status:
COMPLETED
A Study of ART24 in Subjects Recently Cured of a Clostridioides Difficile Infection (CDI)
Lead Sponsor:
Adiso Therapeutics
Conditions:
Clostridium Difficile Infection Recurrence
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 cours...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
February 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04891965
Start Date
February 27 2020
End Date
October 13 2022
Last Update
October 17 2022
Active Locations (15)
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1
Palmtree Clinical Research
Palm Springs, California, United States, 92262
2
Gastro Florida
Clearwater, Florida, United States, 33765
3
Doral Medical Research
Doral, Florida, United States, 33166
4
Louisiana Research Center
Shreveport, Louisiana, United States, 71105