Phase 2 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Launched by VEDANTA BIOSCIENCES, INC. · Dec 21, 2018

Keywords

ClinConnect Summary

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 Clostridioides difficile infection (CDI) -associated diarrhea compared with placebo following completion of at least 1 successful course of standard-of-care (SOC) antibiotics. VE303 or placebo capsules were taken orally for 14 days after completion of a course of SOC antibiotics. The proportions of subjects experiencing a confirmed CDI recurrence within 8 weeks after the first dose of study treatment...

Gender

ALL

Eligibility criteria

• Partial Inclusion Criteria:
• • 1. Able and willing to provide written informed consent
• • 2. 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)
• • 3. CDI symptoms must have started within 30 days (inclusive) prior to the day of randomization
• • 4. The diarrhea was considered unlikely to have another etiology.
• • 5. Completed an Investigator's choice SOC antibiotic regimen of a minimum of 10 days and up to 21 days of total duration
• • 6. Have a positive C. difficile stool
• • 7. Recovered from any complications of severe or fulminant CDI and clinically stable by the time of randomization.
• Partial Exclusion Criteria:
• • 1. 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.
• • 2. Known or suspected toxic megacolon and/or known small bowel ileus at the time of randomization.
• • 3. Contraindication to oral/enteral therapy (e.g., severe reflux, severe nausea/vomiting, or ileus).
• • 4. Prior administration of genetically modified investigational live bacterial/fungal/bacteriophage/viral isolates for CDI-associated diarrhea
• • 5. 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.
• • 6. Use of drugs that alter gut motility
• • 7. History of acute leukemia or hematopoietic stem cell transplantation or myelosuppressive chemotherapy within 2 months prior to randomization.
• • 8. Subjects with compromised immune system
• • 9. 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.
• • 10. History of confirmed celiac disease, inflammatory bowel disease, short gut, gastrointestinal tract fistulas, or ischemia.