VE303 for Prevention of Recurrent Clostridioides Difficile Infection
- Conditions
- Clostridioides Difficile Infection RecurrenceDiarrhea InfectiousClostridium DifficileClostridium Difficile Infection RecurrenceC.Difficile DiarrheaClostridioides Difficile InfectionClostridium Difficile InfectionsC. Diff InfectionRecurrent Clostridium Difficile InfectionCDI
- Interventions
- Biological: Placebo
- Registration Number
- NCT06237452
- Lead Sponsor
- Vedanta Biosciences, Inc.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 852
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Subjects assigned to the placebo arm will take 3 placebo capsules per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode. VE303 VE303 Subjects assigned to the VE303 arm will take 3 capsules containing VE303 per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.
- Primary Outcome Measures
Name Time Method CDI Recurrence Rate at Week 8 8 weeks Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (188)
Advanced Gastroenterology, P.C.
🇺🇸Chandler, Arizona, United States
Om Research, LLC
🇺🇸Apple Valley, California, United States
Science 37 Inc (Remote/Home option)
🇺🇸Culver City, California, United States
VA San Diego Healthcare System
🇺🇸San Diego, California, United States
North America Research Institute
🇺🇸San Dimas, California, United States
Clinical Trials Management Services
🇺🇸Thousand Oaks, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Medical Research Center of Connecticut
🇺🇸Hamden, Connecticut, United States
Gastro Florida
🇺🇸Clearwater, Florida, United States
Proactive Clinical Research, LLC
🇺🇸Fort Lauderdale, Florida, United States
Scroll for more (178 remaining)Advanced Gastroenterology, P.C.🇺🇸Chandler, Arizona, United StatesRebecca MartinezContact480-626-6650Rebecca.martinez@azarthritis.com