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NCT06237452 · ClinicalTrials.gov registry record · Phase 3

VE303 for Prevention of Recurrent Clostridioides Difficile Infection

A Phase 3 study of Clostridioides Difficile Infection and Clostridium Difficile, sponsored by Vedanta Biosciences.

Recruiting
Registry status
Phase 3
Development phase
852
Enrollment target
20
Study locations

NCT06237452: Recruiting Phase 3 study of Clostridioides Difficile Infection and Clostridium Difficile, sponsored by Vedanta Biosciences.

NCT06237452 is a Phase 3 study of Clostridioides Difficile Infection and Clostridium Difficile that is actively recruiting participants, run by Vedanta Biosciences. The registered enrollment target is 852 participants, above the 284-participant average among 6 other Clostridioides Difficile Infection trials with a reported enrollment target (200% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06237452, a Phase 3 study of Clostridioides Difficile Infection and Clostridium Difficile, is actively recruiting participants, sponsored by Vedanta Biosciences.

RECRUITING
Registry status
Phase 3
Development phase
852 participants
Enrollment target
20
Study locations

Study 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).

Primary Outcome

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

Conditions Studied

Clostridioides Difficile Infection Clostridium Difficile Clostridium Difficile Infection Recurrence CDI Recurrent Clostridium Difficile Infection Clostridioides Difficile Infection Recurrence C.Difficile Diarrhea Clostridium Difficile Infections C. Diff Infection Diarrhea Infectious

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL VE303

Study Locations (20)

California

  • Om Research, LLC - Apple Valley
  • Science 37 Inc (Remote/Home option) - Culver City
  • Children's Hospital of Los Angeles - Los Angeles
  • VA San Diego Healthcare System - San Diego
  • North America Research Institute - San Dimas
  • Clinical Trials Management Services - Thousand Oaks
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance

Florida

  • Gastro Florida - Clearwater
  • Proactive Clinical Research, LLC - Fort Lauderdale
  • Encore Borland-Groover Clinical Research - Jacksonville
  • GI Pros Research - Naples
  • Advanced Medical Research Center - Port Orange
  • KM International Research Operation LLC - Saint Cloud
  • James A. Haley Veterans' Hospital - Tampa

Arizona

  • Advanced Gastroenterology, P.C. - Chandler
  • Mayo Clinic Hospital - Phoenix
  • GI Alliance - Sun City

Connecticut

  • Connecticut Clinical Research Institute - Bristol
  • Medical Research Center of Connecticut - Hamden
  • Hartford Hospital - Hartford

Trial Details

FieldValue
Enrollment Target 852 participants
Start Date 2024-05-20
Est. Completion 2027-10
Phase Phase 3
Vedanta Biosciences

5 total trials

What NCT06237452 shows while recruiting

NCT06237452 is an interventional study that assigns participants to a tested intervention. The registered 852 participants enrollment target is mid-sized for trials with a published cap, above the 284-participant average among 6 other Clostridioides Difficile Infection trials with a reported enrollment target (200% higher).

The record links to 10 conditions, with Clostridioides Difficile Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06237452 names 20 study sites across 4 states, led by California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT06237452 about?

NCT06237452 is a clinical study titled "VE303 for Prevention of Recurrent Clostridioides Difficile Infection". 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 ...

What is the current status of trial NCT06237452?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 852 participants. The study started on 2024-05-20. Estimated completion is 2027-10.

What conditions does trial NCT06237452 study?

This clinical trial studies the following conditions: Clostridioides Difficile Infection, Clostridium Difficile, Clostridium Difficile Infection Recurrence, CDI, Recurrent Clostridium Difficile Infection.

What interventions are being tested in trial NCT06237452?

The interventions under investigation include: Placebo (BIOLOGICAL), VE303 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06237452?

This trial is sponsored by Vedanta Biosciences, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06237452 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06237452

Source: ClinicalTrials.gov NCT06237452, the US trial registry maintained by the National Library of Medicine. NCT06237452 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.