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  ♥

 

*PLEASE NOTE

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.”

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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.

Additional Resource Information on clinical trials can be found at http://clinicaltrials.gov/info/resources

SOME 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
Currently Enrolling

SyntheticBiologics2016LOGO

Synthetic Biologics is developing cutting-edge therapeutics to treat pathogen-specific diseases.

UPDATE: On November 21, 2018, Synthetic Biologics announced that it had successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the development of SYN-004 (ribaxamase) for the prevention of antibiotic-mediated Clostridium difficile infection (CDI). Pursuant to the meeting, the FDA has proposed criteria for Phase 3 clinical efficacy and safety which, if achieved, may support submission for marketing approval of ribaxamase on the basis of a single Phase 3 clinical trial. Final agreement on these criteria is contingent on FDA evaluation of a detailed Phase 3 clinical trial protocol.

Synthetic Biologics Clinical Programs Overview

Synthetic Biologics  is a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients.

Our two lead, late-stage candidates are:

SYN-004 (ribaxamase) to prevent antibiotic-mediated microbiome damage, C. difficile infection (CDI), overgrowth of pathogenic organisms and the emergence of antimicrobial resistance (AMR), and;

SYN-010 to treat irritable bowel syndrome with constipation (IBS-C)

SYN-004 (ribaxamase) Phase 3 Clinical Program Update:

  • Announced positive outcome from End-of-Phase 2 meeting with FDA in Q4 2018
  • A single Phase 3 clinical trial may be sufficient for approval for the prevention of antibiotic-mediated Clostridium difficile infection (CDI)
  • The Phase 3 clinical program will entail a single, global, event-driven clinical trial with a fixed maximum number of patients for total enrollment
  • The primary efficacy endpoint of the Phase 3 clinical trial will be the reduction in the incidence of CDI at one month after the last drug dose in the ribaxamase treatment group versus placebo
  • A co-primary safety endpoint of noninferiority will evaluate mortality between the ribaxamase treatment group versus placebo at 3 months post-randomization
  • The Phase 3 patient population will consist of patients at high risk for CDI receiving IV β-lactam antibiotics, and
    • Evaluate multiple β-lactam antibiotics
    • Evaluate different index infections
    • Enroll based on patient risk factors for CDI
  • Synthetic Biologics anticipates initiating the Phase 3 clinical program after securing additional potential financing via a strategic partnership

SYN-010 Phase 2b Clinical Study Update:

  • A research collaboration with Cedars-Sinai Medical Center (CSMC) to co-fund an investigator-sponsored Phase 2b clinical study of SYN-010 was announced on September 6, 2018
    • Patient enrollment was initiated in Q1 2019
    • A topline data readout is expected in 2H 2019
  • The Phase 2b study is being conducted by the Medically Associated Science and Technology (MAST) Program at CSMC and comprises a 12-week, placebo-controlled, double-blind, randomized clinical trial to evaluate two dose strengths of oral SYN-010 (21 mg and 42 mg) in approximately 150 patients diagnosed with IBS-C
  • The primary endpoint for this study will be to determine the efficacy of both dose strengths of SYN-010, measured as an improvement from baseline in the weekly average number of complete spontaneous bowel movements (CSBMs) during the 12-week treatment period relative to placebo
  • Secondary efficacy endpoints for both dose strengths of SYN-010 are expected to measure changes from baseline in abdominal pain, bloating, stool frequency as well as the use of rescue medication relative to placebo
  • Exploratory outcomes include adequate relief and quality of life measures using the well-validated EQ-5D-5L and PAC-SYM patient questionnaires

Click here to see if there’s a study site in the U.S. near you and if you’re eligible.

Click here to learn more about SYN-004.

Updated: January 15, 2019

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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/dav132/
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 Announces Positive Top-Line Results from Phase 2 Study of
Investigational Clostridium difficile Vaccine for the

Pfizer’s C. difficile Vaccine Candidate to Commence Phase 3 Study in First Half of 2017

On Thursday, January 26, 2017  Pfizer Inc. announced that the Phase 2 study evaluating the Company’s Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, provided positive data, based on a pre-planned interim analysis. The randomized Phase 2 study (NCT02561195) examined the safety, tolerability, and immunogenicity of the vaccine in healthy adults 65 to 85 years of age. Pfizer’s vaccine candidate is designed to help prevent

C. difficile infection (CDI), which can include life-threatening diarrhea and pseudomembranous colitis,1 by inducing a functional antibody response capable of neutralizing the two main disease-causing toxins produced by C. difficile (toxins A and B).2

“Despite improved infection control measures, C. difficile disease continues to rise, further augmenting an already urgent public health threat with particular negative impact on older adults,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. “We are very encouraged by these interim immunogenicity and safety results demonstrating robust increases in vaccine-elicited neutralizing antibodies to both toxins, that we believe could provide protection against C. difficile disease.”

Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of January 26, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about a vaccine candidate, PF-06425090, including its potential benefits and the expected timing of commencement of a Phase 3 study, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; risks associated with interim data; whether and when any biologics license applications may be filed for PF-06425090; whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of PF-06425090 and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results,” as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov (link is external) and www.pfizer.com.

1 Cohen SH et al. Infect Control Hosp Epidemiol. 2010;31:431-455.
2 Gerding DN and Young VB. Clostridium difficile infection. In: Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases, 8th ed. Bennett JE, Dolin R, Blaser MJ (eds). Philadelphia, PA: Elsevier Saunders; 2015.
3 U.S. Food and Drug Administration. Fast Track. http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm (link is external). Accessed January 2017.

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A C.diff. Study

Research Study Summary

A Phase 3, Placebo-controlled, Randomized, Observer-blinded Study To Evaluate The Efficacy, Safety, And Tolerability Of A Clostridium Difficile Vaccine In Adults 50 Years Of Age And Older

Purpose

The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated.

Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.

To Learn more

CW ID: 224554
Date Last Changed: May 17, 2017

Phase3, GenderBoth Male and Female,  Age50 and up,  Overall Status Recruiting,  Lead Sponsor: Pfizer,   Duration: 18 Months,  Facility Type:  Out-Patient

LEARN MORE ABOUT THE CLOVER TRIAL Click on the link below

—  The following site is intended for use by United States residents only. If you are located outside of the United States, please refer to www.clinicaltrials.gov.

https://clovertrial.com/en/

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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 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
Currently Enrolling

 

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/our-programmes/c-difficile-infection.

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.

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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 recurrent 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 form Finch 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.

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.

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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