Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection (NCT03788434) | Clinical Trial Compass
CompletedPhase 2
Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
United States79 participantsStarted 2019-02-08
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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.
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.