VE303 for Prevention of Recurrent Clostridioides Difficile Infection

Recruiting Phase 3 Interventional Study
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
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
852 (estimated)
Sponsor
Vedanta Biosciences, Inc. · Industry
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Key Inclusion Criteria (For enrollment in Stage 1: recurrent CDI population): * Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months Key Inclusion Criteria (For enrollment i…
Contacts

Gary Connor

857-706-1427

Consortium02-ctinquiries@vedantabio.com

CONTACT

Steven Shiff, MD

857-706-1427

Consortium02-ctinquiries@vedantabio.com

CONTACT