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clinical trials
The following are a few examples of clinical trials in progress
Every scientific research and development, every clinical trial in progress is a glimmer of hope...........HOPE for clinically safe and approved avenues to prevent and treat a
C. difficile infection.
Listed below you will find a few examples of organizations that have active C. difficile Prevention and Treatment clinical trials in progress. Click on each organization's website listed to review their clinical trial study opportunities -- Inquire if you or your loved one qualify to participate in their study.
To Learn More About Clinical Trials --
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Learn more About Clinical Studies and About This Site, including relevant History, Policies, and Laws. Click on the link below to be redirected to the clinicaltrials.gov website: https://clinicaltrials.gov/
Clinical Studies Are In Progress To
Help Them -- Help You -- Help Others ♥
Below you will find explanations of Clinical Trial Phases:
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
- Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
- Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
THE FOLLOWING ARE A FEW EXAMPLES OF CLINICAL TRIALS AVAILABLE ADDRESSING C.difficile INFECTION PREVENTION AND TREATMENTS.
Visit clinicaltrials.gov for a full listing.
C. diff. Infection Prevention Clinical Studies
is a clinical-stage biotechnology company whose vision is to be a trusted and acknowledged leader in the microbiota field. Da Volterra’s mission is to discover, develop, and bring to market safe and novel therapeutic options, preserving patients’ microbiota to prevent and cure life-threatening diseases. Its most advanced product is DAV132, an oral product to be co-administered with any oral and intravenous antibiotics, to protect patients from antibiotic-induced intestinal microbiota disruption. DAV132 can prevent Clostridioides difficile infection by capturing residual antibiotics in the colon before they can disrupt the intestinal microbiota, without impacting the systemic efficacy of the antibiotics. We see DAV132 as a real game-changer for C. difficile prevention.
Have a look at the DAV132 webpage and video presenting its mechanism of action: https://davolterra.com
The video is highly illustrative of what C. diff. is, how C. diff. is triggered, and how DAV132 could prevent the colonization of the intestinal microbiota by C. diff. and the occurrence of the infection.
Da Volterra has already performed 6 phase 1 clinical trial with DAV132 in healthy volunteers and one phase 2 clinical trial (SHIELD) in patients demonstrating DAV132 favorable safety profile and mechanism of action. The SHIELD study met its primary endpoint: DAV132 was very safe for use in hospitalized patients with several comorbidities and concomitant medications. The study also demonstrated positive results with regards to biological markers of efficacy for prevention of C. difficile infection: DAV132 effectively protected the intestinal microbiota of patients from antibiotic-induced disruption and DAV132 also prevented the proliferation of C. difficile in an ex vivo assay, suggesting that DAV132 is able to protect patients against antibiotic-induced C. difficile infection.
The press release on Da Volterra’s phase 2 SHIELD study results is available here: https://davolterra.com/wp-content/uploads/2020/02/2020-02-11-dav132-phase-2-clinical-trial-pr-vf.pdf
Da Volterra is now preparing for the launch of phase 3 pivotal study of DAV132 in patients who have a high risk of developing Clostridioides difficile infection.
Information on this study is available here: https://clinicaltrials.gov/ct2/show/NCT03710694
“Is another C. diff. infection getting in the way of your life?”
Most Clostridioides difficile (C. diff) infections occur after antibiotic treatment. Why? Our gut contains trillions of microbes, called the microbiome, which protects us from bacterial invaders that can cause disease. Antibiotics disrupt the microbiome by killing both good and bad bacteria. When the microbiome is damaged, bad bacteria, like C diff, can take advantage and cause disease. Although specific antibiotics can kill the active C diff bacteria, the inactive forms (i.e. C diff spores) are untouched. When the microbiome is disrupted, these spores turn into active C diff bacteria and cause disease again and again – usually after antibiotic treatment has finished.
Seres Therapeutics is developing an investigational microbiome drug called SER-109. This medicine is being developed to prevent C diff from coming back by repairing the microbiome. Seres is pleased to announce the positive top-line results from its ECOSPOR-III trial, a Phase 3 trial, reported in August 2020, met its primary endpoint and showed that SER-109 significantly decreased the chance of a recurrence of C. diff in patients who’d had multiple recurrences. Approximately 88% of patients who received SER-109 did not experience a recurrence, compared to approximately 60% of patients who received placebo.
As part of its sustained commitment to patients, Seres may be able to provide access to its investigational drug, SER-109, under certain limited conditions, through its Expanded Access Program (EAP). Seres’ main objective when initiating an EAP is to equitably serve the patient community with compassion and dignity. Seres aims to accomplish this by thoughtfully balancing requests for treatment with the need to protect patient safety and ensure ethical and compliant access to medications. For more information about SER-109 Expanded Access Program, please visit https://www.serestherapeutics.com, then click on “Patients and Physicians” and scroll down to Expanded Access/Compassionate Use.
s a clinical-stage microbiome company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria.
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VE303 is a defined bacterial consortium designed to prevent recurrent C. difficile infections. VE303 is a preparation of eight different bacteria that were selected for their presumed ability to prevent the regrowth of C. difficile.
Why bacterial consortia?
Unlike fecal transplants, which require the use of donors’ stool and are an inherently variable procedure, bacterial consortia therapeutics are defined drug compositions produced from clonally isolated bacteria that can trigger targeted immune responses. And unlike reductionistic approaches such as single strain probiotics, they can robustly shift the gut ecosystem.
The results of the Phase 1 study of VE303 showed both rapid expansion of protective VE303 bacteria in the gut and accelerated recovery to a healthy microbiome after disruption to the normal microbiome in the gut caused by antibiotics. Based on these Phase 1 results, Vedanta is now evaluating VE303 (the “CONSORTIUM” study) in individuals with CDI to see if it can prevent future CDI recurrences by restoring the intestinal bacteria to a healthy state.
About
CONSORTIUM (NCT03788434) is a randomized, double-blind placebo-controlled Phase 2 study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD), and efficacy of VE303 in patients with a recent diagnosis of C. difficile, who have completed a course of antibiotics but remain at risk for recurrence. The primary endpoint will be the prevention of infection recurrence at eight weeks.
CONSORTIUM is currently enrolling participants across North America (U.S. and Canada) who have been diagnosed with high-risk C. difficile infection.
For additional study information or to locate a study site near you, please visit Clinicaltrials.gov:
Artugen is developing a novel oral Live Biotherapeutic Product for the prevention of C. difficile infection recurrence. The investigational drug, ART24 capsules, is composed of freeze-dried gut-derived bacteria called Bacillus amyloliquefaciens which acts directly against the C. difficile bacteria. ART24-1-001 is a blinded study for people with a recent C. difficile infection (first episode or recurrent infection). The study is to see how well ART24 is tolerated and how well ART24 can help prevent future episodes of C. difficile infection compared with placebo.
You may be eligible to participate in ART24-1-001 if you meet these criteria*:
- Greater than or equal to 18 years of age
- Currently taking or have recently finished (within the last 6 days) taking antibiotics for a
C. difficile infection - Do not have inflammatory bowel disease (IBD)
*Other criteria will also apply.
All eligible participants will receive:
- ART24 or placebo
- Study-related medication and exams at no cost
- Compensation for reasonable travel and meal expenses
This study is currently recruiting in the following areas: Butte (MT), Riverton (UT), Shreveport (LA), Doral (FL), Hillsborough (NJ), Bronx (NY), New York (NY), Massapequa (NY/Long Island), Palm Springs (CA), and Boston (MA).
To learn more or join the study please go to https://artugentherapeutics.com/ and click on More Information..
C. diff. Infection Treatment Clinical Studies
Acurx Pharmaceuticals is a publicly held, clinical stage biopharmaceutical company developing a new class of antibiotics for infections caused by bacteria listed as priority pathogens by the World Health Organization, Centers for Disease Control and Prevention, and Food and Drug Administration.
Ibezapolstat (formerly named ACX-362E) is our lead antibiotic candidate. Ibezapolstat is a first-in-class of a new class of Pol IIIC inhibitors which is in clinical development to treat
C. difficile infections Current treatments for C. difficile infections utilize other mechanisms of action while ibezapolstat is the first antibiotic candidate intended to work by blocking the Pol IIIC enzyme in C. difficile. This enzyme is necessary for replication of the DNA of the DNA of the bacterial cell.
Ibezapolstat is active against the GAIN Pathogen Clostridium difficile
C. difficile is a pathogen listed in the GAIN Act as a pathogen that causes serious or life-threatening infections and the CDC identifies a C. difficile infection as an urgent need in terms of generating new antibiotics to treat these infections.
Ibezapolstat (formerly named ACX-362E) is our lead antibiotic candidate. Ibezapolstat is a first-in-class of a new class of Pol IIIC inhibitors which is in clinical development to treat C. difficile infections.
Current treatments for C. difficile infections utilize other mechanisms of action while the first Ibezapolstat antibiotic candidate intended to work by blocking the Pol IIIC enzyme in
C. difficile. This enzyme is necessary for the replication of the DNA of the bacterial cell.
December 2021 Press Release: Acurx Announces First Patient Enrolled in Phase 2b Clinical Trial of its Lead Antibiotic for Treatment of Clostridioides difficile Infection
For more information, please visit the website at wwwacurxpharma.com.
a French biotechnology company, a leader in disruptive innovation, which aims to help meet the challenges of antibiotic resistance and the transition to a sustainable production model for the nutrition and cosmetics industries.
DEINOVE has developed unique and comprehensive expertise in the field of rare bacteria that it can decipher, culture, and optimize to disclose unsuspected possibilities and induce them to produce biobased molecules with activities of interest on an industrial scale. To do so, DEINOVE has been building and documenting since its creation an unparalleled biodiversity bank that it exploits thanks to a unique technological platform in Europe.
This trial is concentrated in the United States. It will take place in two stages:
- In the first phase, involving 5 centers, a cohort of 10 patients with moderate to severe CDI will be treated with DNV3837. At the end of this phase, the DSMB*** will review the interim results.
- The second phase will involve 30 patients with severe CDI and will be carried out in 15 investigation centers. This will be an open-label randomized trial testing DNV3837 (in 2/3 of patients) against an approved standard of care**** (1/3 of patients) for comparison purposes.
For more information: http://www.deinove.com/en
Finch Therapeutics is on a mission to harness the microbiome to transform the lives of patients. Finch is developing CP101, an investigational orally administered microbiome therapy designed to prevent recurrent C. diff. PRISM4, a Phase 3 study of CP101 is currently enrolling individuals with recurrent C. diff who meet the study criteria. To learn more, visit https://www.finchtherapeutics.com/ and click on the ‘Patients’ page.
Rebiotix Inc., a Ferring Company,
is a clinical-stage biotechnology company founded to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome.
It is increasingly recognized that the restoration of healthy gut microbiota is necessary for the effective treatment of a large number of challenging diseases.
Study: The PUNCH CD3-OLS study is a Phase 3 clinical study to assess the safety and tolerability of Rebiotix RBX2660 for the prevention of recurrent Clostridium difficile infection (CDI) in a recurrent CDI population that is broader and more inclusive than that included in prior studies using RBX2660.
This open-label study is expected to enroll up to 200 patients at 80 research sites in the U.S. and Canada. Patients that meet the study requirements and choose to enroll will receive RBX2660, an investigational new drug (no placebo). Study patients whose CDI returns within 8 weeks after study treatment may be scheduled to receive additional RBX2660 treatment. The study’s primary objective is to assess the safety and tolerability of RBX2660 through 6 months after the final RBX2660 study treatment.
Additional information can be found on the Clinicaltrials.gov website https://clinicaltrials.gov/ct2/show/NCT03931941
Or through the Rebiotix website:https://www.rebiotix.com/
Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT™ drug platform. The MRT platform is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract. The lead drug candidate, RBX2660, is currently in Phase 3 clinical development for the prevention of recurrent Clostridium difficile(C. diff) infection. RBX2660 has been granted Fast Track status, Orphan Drug, and Breakthrough Therapy designation from the US FDA for its potential to prevent recurrent C. diff infection. Rebiotix’s clinical pipeline also features RBX7455, a lyophilized, non-frozen, oral capsule part of a recently completed investigator-sponsored Phase 1 trial for the prevention of recurrent C. diff infection. For more information on Rebiotix and its pipeline of human microbiome-directed therapies for diverse disease states, visit www.rebiotix.com.
About Ferring Pharmaceuticals: Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing, and marketing innovative products in the fields of reproductive health, women’s health, urology, gastroenterology, endocrinology, oncology, and orthopedics. For more information, visit www.FerringUSA.com.
Ridinilazole is being developed by Summit Therapeutics as a potential treatment for
C. difficile infections and is not approved by any regulatory body. It’s an investigational antibiotic being studied in adolescent patients with a C. difficile infection. The purpose of the study is to determine whether ridinilazole is safe and effective as compared to the current standard of care. In an earlier clinical trial in patients with a C. difficile infection, ridinilazole was found to have higher sustained clinical response compared to vancomycin. Sustained clinical response measured the if patients were cured after treatment and whether they experienced a recurrence within 30-days post-treatment. More information on ridinilazole can be found by visiting www.summitplc.com/our-programmes/c-difficile-infection.
Some key information about the trial:
· This trial is expected to enroll approximately 40 adolescent patients (12 to ≤ 18 years of age)
· Patients will be randomized to receive either ridinilazole or vancomycin, and neither the patients nor the study doctors will know which drug patients receive
· Participation will involve about 8 study visits and/or telephone contacts over approximately 100 days to track the safety and effectiveness of each drug
· Patients who participate may be reimbursed for travel expenses associated with study site visits
· Patients must have signs and symptoms of a C. difficile infection require C. difficile infection treatment, and have ≥ 3 unformed bowel movements in the 24 hours prior to study randomization
· Patients must have presence of free toxin A and/or B in stool
· There are additional entry criteria and considerations; the study doctors will ultimately decide whether a patient is eligible for entry into the clinical trials and the patient will be required to give consent
For further details regarding this clinical trial please visit https://clinicaltrials.gov/ct2/show/NCT04802837 or the study website at www.ricodifycdiff.com
Is developing a novel antibiotic known as CRS3123 for treatment of C. difficile infection.
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 C. difficile infections 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
C. difficile infection episode in the last three months (or one that was not initially responsive to vancomycin), or two C. difficile infection 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: https://www.crestonepharma.com/
1/2022: THIS IS A PARTIAL LIST OF CLINICAL TRIALS AND TO VIEW A COMPLETE LIST OF CLINICAL TRIALS CURRENTLY ENROLLING -- PLEASE VISIT clinicaltrials.gov
DISCLAIMER
"The C Diff Foundation's mission is to educate and advocate for Clostridium difficile infection prevention, treatments, support, and environmental safety worldwide.
The C Diff Foundation's organization is comprised of 100% volunteering members who are dedicated to our mission and adhere to the Foundation's Code of Ethics
which prohibits the endorsement and paid promotion of products, services, medications, or clinical studies in progress. All website entries, public presentations, and workshops are to raise C. diff. infection awareness in all areas of the C Diff Foundation's mission statement, including, and not limited to, infection prevention, sepsis, healthcare-associated infections, antimicrobial resistance, antibiotic stewardship and provide education on all the above."
