What is a Clinical Trial?
A clinical trial is a research study that using human volunteers that is intended to add to medical knowledge. Clinical trials can vary in size from a single location in one country to multiple locations in multiple countries. Some research studies may determine if an investigational product can be administered to children or special populations. Some studies assess a drug’s long-term effectiveness and its impact on the quality of a person’s life.
All studies of a drug, biological product, or medical device regulated by FDA must be reviewed, approved, and monitored by an institutional review board (IRB) or Ethics Committee (EC). All clinical trials are conducted using Principles of Good Clinical Practice (GCP) and are under the supervision of an IRB or EC whose mission is to ensure the safety and welfare of study participants. To learn more about clinical trials, please visit Clinical Trials.gov.
Treatments
Crestone
Crestone is developing a novel antibiotic known as CRS3123 for treatment of C. difficile infection, or CDI. In preclinical (early) studies CRS3123 has demonstrated that it quickly halts production of C. difficile toxin and spores via a new mechanism of action. In Phase 1 human clinical trials it caused minimal disruption of other, normal gut bacteria. In this Phase 2 study sponsored by NIAID (NIH), Crestone will test two different doses of CRS3123 compared to a standard antibiotic treatment for this infection called vancomycin.
If enrolled, subjects will receive either, 400 mg or 800 mg of CRS3123 or vancomycin for 10 days. Doses will be taken by mouth, every 6 hours. Neither subjects nor study healthcare providers will know which drug is being administered. Then subjects will be followed for an additional 60 days, resulting in about eight outpatient study visits over 70 days. Participants will receive study-related medication and exams at no cost and may be reimbursed for travel expenses for study visits.
The study will enroll subjects 18 or older who have a primary episode or first recurrence of CDI, including diarrhea in the last 24 hours and a positive C. difficile toxin test on a stool sample. They may not participate if they have had more than one CDI episode in the last three months (or one that was not initially responsive to vancomycin), or two CDI episodes in the past twelve months. Pregnant or breastfeeding women may not participate in this study, and other entry criteria apply. Study physicians will determine eligibility and then request subjects’ consent to participate.
This study is currently recruiting in the following areas: Sacramento, CA; Lancaster, CA; Calgary, AB CANADA; London, ON CANADA; St. Petersburg, FL; Miami Lakes, FL; Pompano Beach, FL; Miami, FL; Doral, FL; Idaho Falls, ID; Shreveport, LA; Rochester, MN; Omaha, NE; Mentor, OH; Toledo, OH; Uniontown, PA; Union City, TN; San Antonio, TX; Cedar Park, TX; Houston, TX; Seattle, WA.
To learn more, please visit Crestone’s website CRESTONE C-DIFF Study or to join the study please contact Vicki J Abbas, BSN RN at vabbas@crestonepharma.com or by phone at 303-263-4646.
Vedanta Biosciences
Vedanta Biosciences, Inc. is dedicated to finding treatments for patients with serious infections and immune diseases. VE303 is Vedanta’s investigational treatment for patients with recurrent C. difficile infections (CDI). VE303 is a preparation of eight different types of bacteria grown in clean conditions, dried, powdered and put into capsules to be administered orally. The bacteria are reactivated once they reach the intestines. The 8 bacteria were selected for their ability to provide resistance against C. difficile. In contrast to fecal transplants, which rely on direct sourcing of fecal donor material of inconsistent composition, VE303 is manufactured from pure cell banks that yield a product of uniform composition, free of viruses and uncharacterized bacteria.
In April 2023, Vedanta published results from the Phase II CONSORTIUM trial. The press release can be found here.
PHASE III STUDY
The RESTORATiVE303 Study is a clinical research study that is exploring an investigational drug to restore the microbiome (the bacteria that live in your gut) in people with recurrent Clostridioides difficile infection (CDI). You will be randomly assigned to receive one of two drugs: VE303 or placebo. Placebo looks like VE303 but contains no active medicine. You will be asked to attend around 11 study visits (7 at the study center and 4 virtually) to check on your health and well-being. You will also be given your assigned study drug. You will remain in the study for around 6 months.
An open-label extension to this study is available if you experience a recurrence of CDI while taking part. This means you will receive VE303 for 14 days and not a placebo. This is optional, however, and you do not have to accept this if it is offered to you. You can read more about this study and find a complete list of study locations here.
Vedanta Biosciences has teamed up with Science37 to provide a site-less, decentralized approach. This means the study can be done remotely and the product comes to you, in your home. This allows applicants who are not near a study site or unable to travel to participate and receive treatment. You can sign up for the decentralized study here.
Vaccine & Preventatives
None at this time.
