VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Clostridium Difficile, Clostridium Difficile Infections, Clostridium Difficile Infection Recurrence, Clostridioides Difficile Infection, Clostridioides Difficile Infection Recurrence, CDI, C. Diff Infection, Recurrent Clostridium Difficile Infection, C.Difficile Diarrhea, Diarrhea Infectious
In brief
The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).
Key facts
- Study ID
- NCT06237452
- Run by
- Vedanta Biosciences, Inc.
- People needed
- 852
- Starts
- 2024-05-20
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Snake River Research, PLLC — Idaho Falls, Idaho, United States (enrolling)
- GI Alliance — Gurnee, Illinois, United States (enrolling)
- Gastrointestinal Specialists of Georgia — Marietta, Georgia, United States (enrolling)
- Metro Infectious Disease Consultants — Huntsville, Alabama, United States (enrolling)
- Science 37 Inc (Remote/Home option) — Culver City, California, United States (enrolling)
- Metro Infectious Disease Consultants — Burr Ridge, Illinois, United States (enrolling)
- VA San Diego Healthcare System — San Diego, California, United States (enrolling)
- GI Alliance — Sun City, Arizona, United States (enrolling)
- Clinical Trials Management Services — Thousand Oaks, California, United States (enrolling)
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States (enrolling)
- Connecticut Clinical Research Institute — Bristol, Connecticut, United States (enrolling)
- Medical Research Center of Connecticut — Hamden, Connecticut, United States (enrolling)
- Children's Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
- Gastro Florida — Clearwater, Florida, United States (enrolling)
- Proactive Clinical Research, LLC — Fort Lauderdale, Florida, United States (enrolling)
- Encore Borland-Groover Clinical Research — Jacksonville, Florida, United States (enrolling)
- GI Pros Research — Naples, Florida, United States (enrolling)
- Advanced Medical Research Center — Port Orange, Florida, United States (enrolling)
- KM International Research Operation LLC — Saint Cloud, Florida, United States (enrolling)
- James A. Haley Veterans' Hospital — Tampa, Florida, United States (enrolling)
- International Center for Research — Tampa, Florida, United States (enrolling)
- Summit Clinical Research, LLC — Athens, Georgia, United States (enrolling)
- Emory University Hospital Midtown — Atlanta, Georgia, United States (enrolling)
- Metro Infectious Disease Consultants — Decatur, Georgia, United States (enrolling)
- Indiana University Health University Hospital — Indianapolis, Indiana, United States (enrolling)
Full record on ClinicalTrials.gov
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