Status:
COMPLETED
Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Lead Sponsor:
Vedanta Biosciences, Inc.
Conditions:
Clostridium Difficile Infection Recurrence
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
Detailed Description
CONSORTIUM was a randomized, placebo-controlled double-blind Phase 2 study to evaluate safety, tolerability, pharmacokinetics/pharmacodynamics, and efficacy of VE303 in prevention of subsequent Clostr...
Eligibility Criteria
Inclusion
- Partial
- 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
- 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.
Key Trial Info
Start Date :
February 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2021
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT03788434
Start Date
February 8 2019
End Date
September 15 2021
Last Update
July 3 2023
Active Locations (37)
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1
Phoenix Clinical, LLC
Phoenix, Arizona, United States, 85014
2
Mayo Clinic, Clinical Studies Unit
Phoenix, Arizona, United States, 85054
3
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
4
Alliance Research Institute
Canoga Park, California, United States, 91304