Phase 3: testing VE303 for Clostridium Difficile
The overall objective of the RESTORATiVE303 study is to measure 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 dummy treatment (placebo). The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).
Official registry: https://clinicaltrials.gov/study/NCT06237452 · Vedanta Biosciences, Inc. · enrollment listed as 852
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are VE303, or Placebo. The registry lists allocation as randomized. The overall objective of the RESTORATiVE303 study is to measure 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 dummy treatment (placebo).
They plan to enroll about 852 people at 215 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Interventions: VE303, Placebo
Primary outcome (registry wording): CDI Recurrence Rate at Week 8
Who it is for (from inclusion criteria)
- Ages 12 Years to any
- Key (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 who can join (For enrollment in Stage 2: primary CDI with high-risk for recurrence population):
- Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI
- OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors:
- Kidney dysfunction, defined as estimated creatinine clearance \< 60 mL/min/1.73 m\^2 at the time of the qualifying CDI episode
- History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study
Who the registry excludes
- (For both Stage 1 and Stage 2):
- History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI
- Known or suspected toxic megacolon or small bowel ileus at the time of randomization
- History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis
- Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode
- Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug
- Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study)
Public study contact (from the registry)
Paul McGovern, MD
Consortium02-ctinquiries@vedantabio.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
215 listed- Metro Infectious Disease Consultants — Huntsville, Alabama (recruiting)
- Advanced Gastroenterology, P.C. — Chandler, Arizona (withdrawn)
- Mayo Clinic Hospital — Phoenix, Arizona (withdrawn)
- GI Alliance — Sun City, Arizona (recruiting)
- Om Research, LLC — Apple Valley, California (withdrawn)
- Science 37 Inc (Remote/Home option) — Culver City, California (recruiting)
- Children's Hospital of Los Angeles — Los Angeles, California (recruiting)
- VA San Diego Healthcare System — San Diego, California (recruiting)
- North America Research Institute — San Dimas, California (withdrawn)
- Clinical Trials Management Services — Thousand Oaks, California (recruiting)
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California (recruiting)
- Connecticut Clinical Research Institute — Bristol, Connecticut (recruiting)
+ 131 sites outside the US on the same record
FAQ about this NCT record
Is NCT06237452 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06237452?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06237452?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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