MedPath

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Phase 3
Recruiting
Conditions
Clostridioides Difficile Infection Recurrence
Diarrhea Infectious
Clostridium Difficile
Clostridium Difficile Infection Recurrence
C.Difficile Diarrhea
Clostridioides Difficile Infection
Clostridium Difficile Infections
C. Diff Infection
Recurrent Clostridium Difficile Infection
CDI
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboSubjects 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.
VE303VE303Subjects 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
NameTimeMethod
CDI Recurrence Rate at Week 88 weeks

Proportion of participants with laboratory-confirmed CDI recurrence before or at Week 8.

Secondary Outcome Measures
NameTimeMethod

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 States
Rebecca Martinez
Contact
480-626-6650
Rebecca.martinez@azarthritis.com

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