Clostridium Difficile Infection Recurrence
Conditions
Keywords
Clostridioides difficile, Cdiff, Recurrent Clostridioides difficile
Brief summary
Single-arm trial to evaluate the safety and efficacy of ACX-362E \[ibezapolstat\] in patients with recurrent C. difficile infection (CDI).
Detailed description
Phase 2 multicenter, open-label, single-arm study is designed to evaluate the efficacy, safety, and tolerability of ibezapolstat in the treatment and reduction of recurrence of CDI in an adult patient population that has experienced ≥3 episodes of CDI within the past 12 months. Up to 20 participants will be treated with ibezapolstat 450 mg taken with food every 12 hours for 14 days (28 total doses) and followed for Clinical Cure (Day 16), Sustained Clinical Cure (Day 42), rate of CDI recurrence (Up to Week 24), and Extended Clinical Cure (ECC) (Up to Week 24).
Interventions
DRUGIbezapolstat
Ibezapolstat 450 mg po Q12H x14 days
Sponsors
Acurx Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of CDI as defined by 1) the presence of diarrhea, defined as passage of ≥ 3 UBMs within 24 hours before study Day 1, AND 2) a stool test result positive for the presence of C. difficile free toxins * Three or more CDI episodes in the past 12 months, including the current episode, with each episode defined as ≥ 3 unformed stools in 24 hours associated with positive C. difficile toxin test. * At least 1 of the protocol-qualifying prior CDI episodes, not including the current episode, has been treated with oral vancomycin or with fidaxomicin
Exclusion criteria
* Severe, complicated, or life-threatening fulminant CDI with evidence of hypotension (systolic blood pressure \< 90 mmHg), septic shock, peritoneal signs or ileus, or toxic megacolon * Received more than 24 hours of dosing with antibiotics for the current CDI episode: * Received a live biotherapeutic product (LBP) (Rebyota® or Vowst™) within the past 12 weeks * Received or current use of anti-C. difficile antibodies, eg, IV immunoglobulin \[IVIG\], bezlotoxumab * Active inflammatory bowel disease (Crohn's disease, ulcerative colitis) with chronic diarrhea within 12 weeks before Baseline, or with a history of symptoms \> 12 weeks before Baseline without evidence of mucosal healing on colonoscopy within the past year. * Active irritable bowel syndrome with chronic diarrhea in the past 12 weeks. * Active gastroenteritis because of Salmonella, Shigella, Escherichia coli 0157H7, Yersinia or Campylobacter, other bacteria, a parasite, or a virus within the past 2 weeks * Major GI surgery (eg, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy). * Known current history of a severely compromised immune system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the rate of CDI Clinical Cure (CC) | Day 16 |
| Evaluate the rate of Sustained Clinical Cure (SCC) | Day 42 |
| Evaluate the rate of CDI recurrence (rCDI) | Day 70 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the rate of CDI recurrence (rCDI) | Day 42 | — |
| Assess the effects of ibezapolstat on quantitative changes to the fecal microbiome | Day 1 to Week 24 | The Shannon Diversity Index and Inverse Simpson Diversity Index will be used to quantify biodiversity in a community like the gut microbiome, measuring how many different species are present in a community (richness) and how close in numbers different species in the community are to each other (evenness). |
| Assess time to resolution of diarrhea during the treatment period | Day 16 | — |
| Assess the incidence of Extended Clinical Cure (ECC) | Weeks 8, 12, and 24 | — |
Countries
United States
Contacts
CONTACTDee Rodriguez
Outcome results
None listed