Phase 2
N=79
Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile Infection Recurrence · Clostridium Difficile Infection · Clostridium Difficile · Clostridioides Difficile Infection Recurrence · Clostridioides Difficile Infection
Bottom Line
View on ClinicalTrials.gov: NCT03788434 ↗Enrolled (actual)
79
Serious AEs
9.0%
Results posted
Jul 2023
Primary outcome: Primary: CDI Recurrence Week 8 — 4; 9; 5; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VE303 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vedanta Biosciences, Inc.
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CDI Recurrence Week 8 |
4; 9; 5; 4; 10; 8 | — |
| SECONDARY VE303 Strains Detected |
3.25; 1.62; 0.36 | — |
| SECONDARY VE303 Relative Abundance |
0.01186; 0.00775; 0.00097 | — |
Summary
This study evaluated the safety and efficacy of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).
Eligibility Criteria
Partial Inclusion Criteria:
- Able and willing to provide written informed consent
- Subjects with a qualifying CDI episode who had a prior history of CDI diarrhea (≥ 18 years of age) or first occurrence of CDI diarrhea with a higher risk for recurrence (≥ 75 years of age, or ≥ 65 years of age with one or more prespecified conditions)
- CDI symptoms must have started within 30 days (inclusive) prior to the day of randomization
- The diarrhea was considered unlikely to have another etiology.
- Completed an Investigator's choice SOC antibiotic regimen of a minimum of 10 days and up to 21 days of total duration
- Have a positive C. difficile stool
- Recovered from any complications of severe or fulminant CDI and clinically stable by the time of randomization.
Partial Exclusion Criteria:
- History of diarrhea (defined as 3 or more loose stools per day lasting for at least 4 weeks) that was not related to C. difficile infection within the 3 months prior to randomization.
- Known or suspected toxic megacolon and/or known small bowel ileus at the time of randomization.
- Contraindication to oral/enteral therapy (e.g., severe reflux, severe nausea/vomiting, or ileus).
- Prior administration of genetically modified investigational live bacterial/fungal/bacteriophage/viral isolates for CDI-associated diarrhea
- History of administration of fecally-derived investigational live biotherapeutic products, or fecally-derived live bacterial isolates for CDI-associated diarrhea including fecal microbiota transplantation (FMT) within the last 6 months.
- Use of drugs that alter gut motility
- History of acute leukemia or hematopoietic stem cell transplantation or myelosuppressive chemotherapy within 2 months prior to randomization.
- Subjects with compromised immune system
- Major gastrointestinal surgery (e.g., significant bowel resection or diversion) within 3 months prior to randomization or any history of total colectomy or bariatric surgery that disrupts the gastrointestinal lumen.
- History of confirmed celiac disease, inflammatory bowel disease, short gut, gastrointestinal tract fistulas, or ischemia.
Data sourced from ClinicalTrials.gov (NCT03788434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.