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 who 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  ♥

Here is a listing and 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.

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  C. diff. Infection (CDI)_Prevention Clinical Studies

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DAV-Logo (2)

Da Volterra is a is a clinical stage biotechnology company whose vision is to be a trusted and acknowledged leader in the microbiota field. Our mission is to discover, develop and bring to market safe and novel therapeutic options, preserving patients’ microbiota to prevent and cure life-threatening diseases. Our most advanced product is DAV132, an oral product to be co-administered with any antibiotics, in order to protect patients from antibiotic-induced intestinal microbiota disruption. DAV132 decreases the risk of triggering Clostridium difficile infection by inactivating residual antibiotics in the colon
before they can disrupt the bacterial flora, without impacting the systemic efficacy of the antibiotics.

It is noteworthy that DAV132 is developed to accompany all oral and intravenous antibiotics of any class and would therefore significantly reduce the risks to acquire C.difficile infections for patients at risk. We see DAV132 as a real game changer for C.difficile prevention.

Have a look at DAV132 webpage and video presenting its mechanism of action: https://davolterra.com
The video is highly illustrative of what C.diff is and how C.diff is triggered.

We have already performed 4 clinical trials with DAV132 in healthy volunteers and we have a very exciting dataset (both preclinical and clinical) suggesting that DAV132 will very effectively prevent C.diff infections. We are currently conducting a clinical trial, in patients actually treated with antibiotics and at-risk of C.diff.             

Information on this study is available here: https://clinicaltrials.gov/ct2/show/NCT03710694

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Pfizer, a leader in vaccine research and innovation, continues to advance its Clostridium difficile (C. difficile) vaccine candidate, PF-06425090. The Phase 3 trial CLOstridium difficile Vaccine Efficacy TRial (CLOVER), is an ongoing placebo-controlled trial designed to assess whether PF-06425090 prevents the disease, and whether it is safe and well-tolerated in adults 50 years of age and older. [i], [ii]

Additional information about CLOVER can be found at CloverTrial.com.

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Seres Therapeutics

“Is another C. diff.  infection getting in the way of your life?”

Seres Therapeutics is developing Ecobiotic® drugs designed to prevent C diff infections from coming back again.

Most 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 kill both good and bad bacteria, leaving holes in this ecology (community) of microbes. 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 sleeping forms (ie, spores) are untouched. These spores turn into active C diff bacteria and cause disease again and again – usually after antibiotic treatment has finished.

Seres Therapeutics has developed an oral medicine called SER-109, which aims to prevent C diff from coming back by repairing the microbiome. This Ecobiotic® drug is being studied in a large Phase 3 clinical trial that is enrolling patients who have had multiple C diff infections. This important clinical study is being done in the United States and Canada and may provide the final clinical data needed to support FDA and Canadian drug approvals.

To learn more about Seres Therapeutics and Clinical Trials In Progress please click on the following link to be redirected:

www.serestherapeutics.com

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Valneva Clinical Trial of its Clostridium difficile vaccine candidate

UPDATE:  February 2019

Valneva’s Clostridium difficile vaccine candidate – VLA84

Valneva successfully completed Phase 2 development of its prophylactic vaccine candidate against Clostridium difficile infection, confirming previously announced positive topline data. The vaccine candidate VLA84 is Phase 3 ready.

Valneva seeks to partner its Clostridium difficile vaccine candidate. At this point, however, potential partners are hesitant about the level of investment required to fund a Phase 3 clinical trial. Therefore, the Company reviewed its development and partnering approach. Valneva will consider using the first CDI vaccine approval and to conduct a head to head, non-inferiority Phase 3 trial, based on an immunological correlate that is expected to substantially improve the investment – risk profile of an in-house, or partnered, development to market.

The Company estimates that the total market potential for prophylactic C. difficile products may exceed $1 billion annually.

 

BACKGROUND:    Lyon (France), December 18, 2014European biotechnology company Valneva SE (“Valneva”) announced today the initiation of the Phase II clinical trial of its VLA84 prophylactic vaccine candidate against Clostridium difficile (C. difficile), the main cause of nosocomial diarrhea. Data from the Phase I study in healthy elderly and adults showed good safety and immunogenicity of the vaccine candidate, and indicated functionality of induced antibodies, supporting the Company`s decision to progress the vaccine
candidate into Phase II

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C. diff. Infection (CDI) Treatments

Clinical Studies

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Acurx Pharmaceuticals, LLC  a privately held, clinical stage, biopharmaceutical company developing new antibiotics for difficult-to-treat bacterial infections, announced that its lead product candidate, ACX-362E, has successfully completed the 68-subject, double-blind, placebo-controlled, multiple-ascending dose Phase 1 clinical trial of ACX-362E in healthy volunteers.  The Phase 1 clinical trial was first-in-man for a new class of antibiotics  which work by inhibiting DNA synthesis in certain bacterial cells (pol IIIC inhibitors).  Pol IIIC is required for DNA replication of many Gram-positive pathogens, including  Clostridioides  as well as Enterococcus, Staphylococcus, and Streptococcus.  Multiple dose levels up to 450 mg BID for 10 days were shown to be well tolerated. Any adverse events attributed to ACX-362E were mild, transitory, and did not interrupt treatment in any subject. Blood levels of ACX-362E show low systemic exposure,  indicating poor oral absorption and desirable in treating CDI.  Additionally, fecal concentrations of ACX-362E at higher dose levels rapidly exceeded the concentrations known to inhibit C. difficile by several hundred-fold and were sustained for the duration of the 10-day treatment period. Detailed data will be presented at the 7th Annual International C. difficile Conference in St. Louis on November 6 to 7, 2019.

ACX-362E is a novel, oral antibacterial agent for the treatment of Clostridioides difficile infection (CDI), an acute, serious, potentially life-threatening, intestinal infection. This Phase 1 study included a 6-subject vancomycin treatment arm (the current standard of care for CDI) for comparative microbiome analysis by Dr. Kevin Garey, Professor, University of Houston College of Pharmacy and Principal Investigator for this aspect of the trial.  ACX-362E effects on the fecal microbiome were compared to those produced by vancomycin over the 10-day treatment course. The results demonstrate that while vancomycin significantly disrupts Bacteroidetes and Firmicutes, deemed to constitute more than 80% of the favorable microbiota in the gastrointestinal tract, ACX-362E had minimal impact on the Bacteroidetes and Firmicutes.  Specifically, vancomycin treatment resulted in a 3-4 log reduction in Bacteroides while ACX-362E doses of 300 or 450 mg BID showed minimal effect.

Dr. Garey stated, “The safety data are impressive with fecal concentrations comparable to those observed with precedent products that have advanced to demonstrate clinical success. For example, Bacteroides is one of the predominant species in the normal gut microbiome, and one of the most important in preventing colonization with C. difficile. Bacteroides represents the Bacteroidetes family of bacteria, which along with Firmicutes comprise the predominant portion of the normal gut flora often reported to exceed 80% of the microbiome.”  He stated further, “The minimal disruption to the healthy gut microbiome identified in this Phase 1 study population should offer advantages over other therapeutic options for an initial episode of CDI if these salutary effects on the gut microbiome translate into the clinical benefit of reducing recurrent infection.”

“We are very encouraged by these data showing that at well-tolerated doses ACX-362E reaches concentrations in the colon that are anticipated to have a highly favorable therapeutic index for patients with CDI,” said Robert J. DeLuccia, Co-Founder and Managing Partner of Acurx.  “The safety, fecal concentration, low systemic exposure and, most importantly, the minimal impact on the healthy gut microbiome provide data to guide selection of our Phase 2 dose and improve the probability of success and timeline efficiency of our Phase 2 clinical trial program.”

About the Phase 1 Clinical Trial
The Phase 1 trial was a double-blind, placebo-controlled study to determine safety, tolerability, pharmacokinetics and fecal concentrations of ACX-362E in healthy volunteers conducted in the U.S.  A total of 68 subjects, of which 44 were given active drug, were enrolled in 3 parts: Part 1, Single-ascending dose (n = 32); 6 active/2 placebo per dose cohorts of 150, 300, 600, and 900 mg; Part 2: Food-effect crossover at 300 mg (n = 8); Part 3: Multiple-ascending dose (n = 22); 6 active/2 placebo per dose cohort; BID dosing x10 days; 30-day follow-up visit for microbiome sampling; dose cohorts of 300 and 450 mg.  Additionally, it included an “Active” control group for microbiome studies, oral vancomycin q6H x10 days (n = 6)

Safety information was analyzed through assessment of adverse events and other standard safety measures, while concentrations of ACX-362E were determined in both the blood and the feces, the latter being the critical site of drug delivery for treating CDI.  In addition, Acurx partnered with Dr. Kevin Garey’s laboratory at the University of Houston to perform state-of-the-art microbiome testing of gastrointestinal flora in trial subjects.

About ACX-362E, FDA QIDP and Fast Track Designation
FDA granted Fast Track Designation to ACX-362E in January, 2019.  FDA Fast Track Designation is a process designed to facilitate the development and expedite the regulatory pathway of new drugs to treat serious or life-threatening conditions and that fill a high unmet medical need. ACX-362E is a novel, first-in-class, orally administered antibacterial.  It is the first of a novel class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Acurx acquired ACX-362E from GLSynthesis, Inc. in February 2018.

ACX-362E is a Qualified Infectious Disease Product (QIDP) for the oral treatment of patients with Clostridium difficile infection (CDI).  Under QIDP designation, ACX-362E will now be eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (the GAIN Act). These incentives include Priority Review and eligibility for Fast Track status, the latter of which Acurx has already applied for and been granted by FDA. Further, if ultimately approved by the FDA, ACX-362E is eligible for an additional five-year extension of Hatch-Waxman marketing exclusivity.  ACX-362E is being developed as a targeted, narrow spectrum oral antibiotic for the treatment of patients with CDI.  Acurx is planning to advance ACX-362E into a Phase 2 clinical trial in first quarter 2020. The CDC (Centers for Disease Control & Prevention) has designated Clostridium difficile bacteria as an urgent threat highlighting the need for new antibiotics to treat CDI.

About DNA polymerase IIIC (pol IIIC)
Building on the mechanism of action of ACX-362E, Acurx’s lead product candidate, which acts as a DNA polymerase IIIC inhibitor and targets the oral treatment of CDI (C. difficile Infection), Acurx has identified additional potential therapeutic candidates to add to its pipeline. Nonclinical research has established the mechanism of action of ACX-362E as the selective inhibition of the enzyme DNA polymerase IIIC (pol IIIC), which is required for bacterial replication and pathogenesis. This enzyme is found only in certain Gram-positive bacteria, including C. difficile as well as the pathogens Enterococcus (including vancomycin-resistant strains or VRE), Staphylococcus (including methicillin-resistant strains or MRSA), and Streptococcus (including antibiotic-resistant strains). Accordingly, chemically related molecules with the same mechanism of action as ACX-362E have the potential to treat a variety of serious systemic Gram-positive infectious diseases.For more information, please visit our website at wwwacurxpharma.com.

View original content:http://www.prnewswire.com/news-releases/acurx-successfully-completes-ph1-clinical-trial-for-acx-362e-in-cdi-300908613.html

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Study: Bezlotoxumab Versus Placebo in Children With Clostridium difficile Infection (CDI) (MODIFY III)

Recruitment Status: Recruiting

The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab in children aged 1 to <18 years with a confirmed diagnosis of CDI who are receiving antibacterial drug treatment for this infection. (Source = ClinicalTrials.gov)

Click here to learn more about this study

Click here to see if there’s a site near you

 For Additional Site and Study Information:

Toll Free: 1-888-577-8839

Email: Trialsites@merck.com

 ZINPLAVA™ (bezlotoxumab):

ZINPLAVA is a prescription medicine used to help decrease the risk of C-diff from coming back in people 18 years of age or older who are taking an antibiotic for C-diff and who have a high risk of C-diff coming back. C-diff is a bacterial infection that can damage your colon and cause stomach pain and severe diarrhea.

When people get C-diff, they often take an antibiotic to get rid of the infection. Even when treated by an antibiotic, C-diff can come back within weeks to months. ZINPLAVA helps to decrease the risk of the infection from coming back. It works when given along with the antibiotic that you are taking to treat C-diff. (Source = zinplava.com)

Click here to learn more about ZINPLAVA (bezlotoxumab)

 Study Sponsor: Merck

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Summit Therapeutics  Ridinilazole is being developed by Summit Therapeutics as a potential treatment for
C. difficile infection (CDI). It’s a new antibiotic, and Summit is testing whether it can improve patient outcomes over the current standard of care, vancomycin, in two global clinical trials. In an earlier clinical trial in patients with CDI, ridinilazole was found to be superior to vancomycin in a measure called sustained clinical response, which tested if patients were cured after treatment and did not experience a recurrence within 30-days post-treatment. More information on ridinilazole can be found by visiting www.summitplc.com

Some key information about the trials:

  • Each trial is expected to enroll up to 680 patients
  • Patients will be randomized to receive either ridinilazole or vancomycin, and neither the patients nor the study doctors will know which drug they receive
  • Participation will involve about 7 study visits 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 be 18 years of age or older
  • Patients must have signs and symptoms of CDI, including diarrhea, in the 24 hours prior to entry in the trial and a positive toxin test on a stool sample produced within 72 hours of entry into the trial
  • Patients cannot have had more than one prior episode of CDI in the previous three months or more than three episodes in the past 12 months
  • Patients cannot have had more than 24 hours of CDI antibiotic treatment prior to entry into the trial
  • 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

Further details of the global clinical trials can be found by visiting: https://clinicaltrials.gov/ct2/show/NCT03595566 and https://clinicaltrials.gov/ct2/show/NCT03595553, and/or by speaking with one of the clinical trial sites.

The clinical trials will be taking place at sites in the US, Europe, Latin America, Australia and Asia. If you would like to be considered for enrollment into one of the clinical trials, please contact the study site nearest you.

ridinilazole has already received Qualified Infectious Disease Product, or QIDP, designation and has been granted Fast Track status from the US Food and Drug Administration

To learn more about ridinilazole and Summit Therapeutics, click on the following link

to be redirected to the Summit Therapeutics website:  https://www.summitplc.com/

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rebiotixlogoRebiotix Inc. is a clinical stage biotechnology company founded to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome. Microbiota Restoration Therapy (MRT) is the company’s platform for delivering live microbes into a sick patient’s intestinal tract to treat disease.

Study: PUNCH CD 3 (Currently Enrolling)  *Updated 9/2018

About

The PUNCH CD 3 study is a Phase 3 clinical study to evaluate the safety and efficacy of Rebiotix RBX2660 for the prevention of recurrent Clostridium difficile infection (CDI).

This prospective, randomized, double-blinded, placebo-controlled clinical research study is expected to enroll up to 270 patients at 60 research sites in the U.S. and Canada. Patients that meet the study requirements and choose to enroll will be randomized to receive either RBX2660, an investigational new drug, or a placebo. Two out of every three study patients will receive RBX2660, and one out of every three study patients will receive the placebo study treatment (2:1 randomization). Study patients whose CDI returns within 8 weeks after blinded study treatment may be scheduled to receive an RBX2660 treatment (no placebo). The study’s primary endpoint will compare the proportion of patients with treatment success following treatment with RBX2660 to prevent recurrent CDI within 8 weeks of blinded treatment as compared to placebo.

Detailed Information & Site Locations

Visit: clinicaltrials.gov

Study Participation

Email:  studyinfo@rebiotix.com

Caution: Drug products are in development and investigational at this time. No product has yet been approved by the U.S. Food and Drug Administration.

Rebiotix Inc., part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionise the treatment of challenging diseases. Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT™ drug platform. The MRT platform is a standardised, stabilised 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 orthopaedics. For more information,  visit www.FerringUSA.com.

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  • Having reached a sufficient number of clinical centers, Phase II clinical trial testing the antibiotic candidate DNV3837 in Clostridioides[1] (Clostridium) difficile infections will start this summer in the United States and Germany 
  • This trial will be conducted as part of an active Investigational New Drug (IND) authorization and a recently updated version of the clinical protocol
  • The production of the first commercial batch of DNV3837 has been successfully initiated

DEINOVE (Euronext Growth Paris: ALDEI), a French biotech company that uses a disruptive approach to develop innovative antibiotics and bio-based active ingredients for cosmetics and nutrition, announced that all the conditions are in place for the upcoming start of the Phase II trial testing the antibiotic candidate DNV3837 for the treatment of Clostridioides difficile infections.

DNV3837 is a first-in-class antibiotic candidate targeting the treatment of Clostridioides difficile infections (CDIs), a disease classified as a priority by the WHO and one of the global leading causes of healthcare-related infections[2]. DNV3837 has demonstrated a promising efficacy profile, and acceptable tolerance in Phase I trials. It has obtained a QIDP designation and a Fast Track status[

DNV3837 will now enter Phase II trial for the treatment of CDIs. The clinical protocol has recently been adjusted and allows the trial to be conducted under the IND initially granted for the compound.

This multicentric open-label trial will be conducted both in Germany and the United States. Under the updated protocol, the number of sites, necessary for the implementation of its Phase II, has been reached. The inclusion of the first patient is planned for mid-2019. Medpace (Nasdaq: MEDP) was chosen as the Clinical Research Organization to oversee the trial.

In parallel, DEINOVE has started the production of the first DNV3837 batch on a commercial scale, in accordance with good manufacturing practices. This batch will be used in order to prepare enough material for conducting Phase III trial. CMC (Chemistry, Manufacturing, and Controls) operations in the United States have been contracted to a recognized CMO and the first production steps have been successfully completed in accordance with the agreed specifications.

For more information:  http://www.deinove.com/en

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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 bacteria which were selected for their apparent ability to prevent the regrowth of C. Difficile.

The selected bacteria are grown in clean controlled conditions, dried, powdered and put into capsules for oral administration where the bacteria become reactivated once they reach the intestines.  VE303 is manufactured from pure cell banks that yield a product of uniform composition, free of viruses and uncharacterized bacteria which is in contrast to fecal transplants, that rely on direct sourcing of fecal donor material of inconsistent composition.

The results of Phase 1 study of VE303 in healthy volunteers 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 (“CONSORTIUM”) in individuals with recurrent CDI to see if it can prevent future CDI recurrences by restoring the intestinal bacteria to a healthy state.

CONSORTIUM STUDY

The CONSORTIUM Study is enrolling up to 146 participants over the age of 18 years old with any number of CDI episodes, including the current episode, to be enrolled in the CONSORTIUM Study.  Two out of every three study patients will receive VE303, and one out of every three Study participants will receive the placebo treatment (2:1 randomization) upon completion of standard antibiotic treatment.  CONSORTIUM’s primary objective is to determine the safety and effectiveness of VE303 at preventing CDI recurrence within 8 weeks of completion of antibiotic treatment.

CONSORTIUM is currently enrolling participants across North America (U.S. and Canada) who have been diagnosed with recurrent CDI.  To learn more about the Study and to locate a Study site near you, please visit: https://www.clinicaltrials.gov/ct2/show/NCT03788434

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In October of 2017 Finch merged with Crestovo to formFinch Therapeutics Group.

The PRISM 3 clinical study is for patients who have had a recurrence of Clostridium difficile infection (CDI or C. diff). The study is evaluating the safety and effectiveness of the study drug (CP101) to prevent recurrence of CDI compared to a placebo. The study is currently enrolling across the United States.

This clinical trial (CP101) is in Phase 2.  For more information from
http://www.ClinicalTrials.gov  click on the following link:

https://www.clinicaltrials.gov/ct2/show/NCT03110133?term=PRISM+3&rank=3

The study drug, CP101, is a Full-Spectrum Microbiota™ investigational drug designed to deliver bacteria to the intestine. This bacteria may help overtake the surplus of C. diff. bacteria that cause CDI.

CP101 is encapsulated for oral administration. The powder is intended to be released from the capsules in the right part of your intestine where the bacteria may repopulate. This may aid in restoring the diverse community of bacteria found in the healthy human gut, which may prevent recurrence of C. diff..

Click here to learn more about PRISM 3 (https://www.prism3trial.com/trial) and see if there is a study near you and if you are eligible.

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CP101 drug products are in development and investigational at this time. No product has yet been approved by the U.S. Food and Drug Administration.Prolacta Bioscience is a company dedicated to Advancing the Science of Human Milk. It has been leading the way in developing human milk-based nutritional products for premature and other infants with special nutritional needs since 2005.

Prolacta has recently developed a potential therapeutic, consisting of beneficial components derived from human milk and is investigating its usefulness in the treatment of C. difficile associated diarrhea.  In a healthy individual, the bacteria population living in the gut (microbiome) provides many health benefits and can prevent pathogens from causing infections. Antibiotics wipe out the beneficial bacteria in the gut and can allow harmful bacteria such as C. difficile to overgrow.

C. difficile causes disease by producing toxins that injure the cells of the gut wall. Although some specific antibiotics can cure C. difficile infections, at times the pathogen can resist antibiotics by forming spores. These C. difficile spores are immune to the effects of antibiotics and, under certain conditions, can become harmful active bacteria, which start the disease cycle all over again. If the gut microbiome does not return to a healthy state, the C. difficile infection may still return after each antibiotic treatment.

Prolacta’s new product has natural biological activities that could help restore the individual’s healthy gut microbiome and support immune function in order to potentially reduce the risk of a relapse of C. difficile disease without having to introduce a new bacterial population collected from outside sources.

Some Key Information about the trial:
• Patients will be given liquid product (consisting of human milk-derived components) or placebo, administered orally three times daily for seven days
• Phase I Study
• Double-blind, randomized, placebo-controlled dose escalation trial
• Study subjects will receive one of three doses depending upon which dose group is recruiting at the time of their participation.
• Currently enrolling patients age 18 or older who have had no more than four prior occurrences of C. difficile associated diarrhea (CDAD) and are currently being treated with standard of care antibiotics.
• The target enrollment number is between 48 and 54.

The clinical trial will be taking place at the following locations in the US:
– Idaho Falls, ID Orlando, FL
– Butte, MT Miami-Dade, FL
– Omaha, NE Tampa, FL
– Ventura, CA New York, NY
For further information contact:  info@prolacta.com

case/control number C.diff. trial : NCT03793686

clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT03793686?term=Prolacta&rank=3

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MERCKBW2015_medLogoBLK [Converted] (2)

 

DIFICID (fidaxomicin) is currently FDA approved to treat Clostridium difficile-associated diarrhea (CDAD) in adult patients 18 years of age and older.

Currently, clinical trials are ongoing to assess the efficacy and safety of DIFICID, in either a tablet and oral suspension formulation, in pediatric patients with CDAD.  **  In addition, DIFICID is currently in clinical trials to determine the efficacy of use as a prophylaxis against CDAD in adult patients undergoing hematopoietic stem cell transplantation (HSCT).

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2/2019 :  A PARTIAL LIST OF CLINICAL TRIALS UPCOMING

AND

CLINICAL TRIALS CURRENTLY ENROLLING —  FOR THE FULL LISTING VISIT clinicaltrials.gov

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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.”