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Prevention study for Clostridium Difficile
Official title VE303 for Prevention of Recurrent Clostridioides Difficile Infection
ClinicalTrials.gov ID: NCT06237452
What this study is testing
What is VE303?
VE303 is an investigational medicine, being studied as a potential treatment for clostridium difficile.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
- 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:
- Age ≥ 65 years
You likely can't join if
- (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...
- 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...
- 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
See the full eligibility criteria
- 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 (For enrollment in Stage 2: primary...
- 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:
- Age ≥ 65 years
- 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
- History of a prior CDI episode between 6 and 12 months prior to enrollment
- Immunosuppression due to an underlying disease or its treatment
- Has undergone solid organ or hematopoietic stem cell transplantation Key (For enrollment in Stage 1 or 2):
- The qualifying episode of CDI must meet all the following criteria:
- New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days
- CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI
- Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, defined as enzyme immunoassay (EIA) for toxin A/B and glutamate...
- Diarrhea considered unlikely to have another etiology
- Prior to receiving any study medication, the participant should:
- Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (Note: choice of agent is at the physician's discretion and antibiotic tapering is not allowed). It is permissible...
- Meet the criterion of a successful clinical response, defined attaining symptomatic control of the qualifying CDI episode, ie, \< 3 loose/unformed bowel movements per 24 hours for at least 2 consecutive days
- Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration for a qualifying CDI episode, or no later than 2 days after completion of antibiotic dosing
- Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization Key
- (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)
- Probiotics, whether characterized as a dietary/food supplement, or a drug, are prohibited within 2 days before starting study drug and through the dosing period. (Note: consumption of food-based products such as yogurt...
- Absolute neutrophil count (ANC) of \< 0.5 ×10\^9 cells/L on 2 consecutive occasions within 7 days prior to randomization, or sustained ANC \< 1.0 × 10\^9 cells/L
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Sun City, Arizona, United States
- Apple Valley, California, United States
- Culver City, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- San Dimas, California, United States
- Thousand Oaks, California, United States
- Torrance, California, United States
- Bristol, Connecticut, United States
- Hamden, Connecticut, United States
- Hartford, Connecticut, United States
- Clearwater, Florida, United States
- Fort Lauderdale, Florida, United States
- Jacksonville, Florida, United States
- Naples, Florida, United States
- Port Orange, Florida, United States
- Saint Cloud, Florida, United States
+ 177 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Chandler, Arizona, United States; Phoenix, Arizona, United States; Sun City, Arizona, United States; Apple Valley, California, United States; Culver City, California, United States and 191 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.