Tag Archives: cdiffense

C Diff Foundation Shares a Community Of Clinical Studies In Progress Focused On Clostridium difficile (C.diff.) Prevention and Treatments Worldwide

Clinical Studies In Progress To Help You — Help Them — Help Others  ♥

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
.

For More Information — Visit The ClinicalTrials.gov Website

https://clinicaltrials.gov/

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.

 

Listed below you will find information pertaining to organizations who have active 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. 


*Please note:  The C Diff Foundation does not endorse any products and/or clinical study in progress. All website postings are strictly for informational purposes only.

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Here is a list 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

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  C. diff. Infection (CDI)_Prevention on the Horizon

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Synthetic Biologics’ SYN-004 Phase 2b Proof-of-Concept Clinical Trial

 A global, multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the ability of SYN-004 to degrade certain IV beta-lactam antibiotics within the GI tract to maintain the natural balance of the gut microbiome for the prevention of C. difficile infection, C. difficile associated diarrhea and antibiotic-associated diarrhea in patients hospitalized for a lower respiratory tract infection and receiving IV ceftriaxone.

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: 4/14/2016

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On March 1, 2016: Cdiffense Phase III Trial updates discussed with Doctors of Sanofi Pasteur To listen to the Podcast ~ Click on the Sanofi Pasteur Logo below and enjoy listening to the Sanofi Pasteur “Cdiffense” clinical updates.

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Sanofi Pasteur, one of the leading vaccine manufacturers in the world, is in the midst of its Phase III clinical trial called Cdiffense to study its investigational vaccine to prevent Clostridium difficile infection (CDI). The trial is now in more than 20 countries across 5 continents to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary, symptomatic CDI. The investigational C. diff vaccine is designed to produce an immune response that targets the toxins generated by C. diff bacteria, which can cause inflammation of the gut. The investigative vaccine ultimately may help prevent a future infection from occurring. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization or have had at least two hospital stays and have received systemic antibiotics in the past year. For more information on the Cdiffense trial, please visit www.cdiffense.org

For more information, visit www.cdiffense.org

 WATCH this video to learn more about Clostridium diffiicle and Cdiffense

https://youtu.be/IPunIvOaurA

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Da Volterra is a biopharmaceutical company, privately-held and headquartered in Paris (France), focused on the discovery and development of innovative therapeutic and preventive products for Clostridium difficile and multi-resistant infections. Our most advanced product, DAV132, is designed as a prophylactic treatment intended to prevent the development of
C. difficile infection, by binding with and neutralizing common antibiotics in the gut
.
DAV132 decreases the risk of triggering CDI 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 (especially patients who had prior episodes). We see DAV132 as a real game changer for C.difficile prevention.

Have a look at our video presenting the mechanism of action of DAV132:

http://davolterra.com/content/dav132-preventing-occurence-and-recurrence-clostridium-difficile-infections-video

The video is highly illustrative of what C.diff is and how C.diff is triggered.

We have already performed 2 clinical trials with DAV132 and we have a very exciting dataset (both preclinical and clinical) suggesting that DAV132 will very effectively prevent C.diff infections. I would be happy to exchange with you more information on this. Our next clinical trial, in patients actually treated with antibiotics and at-risk of C.diff, will start in Q4 2015 or early 2016.

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Valneva Announces Start of Phase II Clinical Trial of its Clostridium difficile vaccine candidate

  • First Study participant(s) enrolled in Phase II trial which aims to enable Phase III entry upon successful completion
  • Study to enroll 500 healthy subjects aged 50 years and older in the United States and Germany
  • First results are expected in Q4 2015

   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 On the Horizon

Seres Therapeutics is a clinical-stage therapeutics company focused on discovering and developing drugs to treat diseases of the microbiome. The biology of the microbiome is driven by ecologies—the functional collections of various organisms—which are central to health and disease. Seres is developing Ecobiotic® therapeutics to treat diseases where an abnormal (unhealthy) microbiome is a significant factor in the underlying cause of the disease. Our first clinical program, The ECOSPOR Research study is in the treatment of recurrent
Clostridium difficile infection.
About The ECOSPOR Research Study  Although antibiotics are used to treat recurrent
C. difficile infection, most of the time they do not cure C. difficile. In addition, antibiotics continue to wipe out the good bacteria that protect you
against C. difficile. Currently, there are no medications available that can prevent this infection from coming back when your gut is defenseless.

SER-109 is an investigational medicine being developed to prevent recurrent C. difficile from coming back again. The idea is to first treat patients with antibiotics that work against C. difficile so that the diarrhea goes away. Then patients may get SER-109 to keep the C. difficile infection from coming back.

In the ECOSPOR study, doctors will compare SER-109 to a placebo pill, which looks like SER-109. However, the placebo pill will have no medication inside it. Patients will be randomly assigned to receive either SER-109 or placebo. The study is designed to provide more information about the potential safety and effectiveness of SER-109, and will last about 7 months. The results will help doctors and researchers learn whether SER-109 could one day be used to prevent recurrent CDI.

Who Is Eligible For The ECOSPOR Study?
To pre-qualify for this study, a person must:
• Be 18 years of age or older
• Have a history of at least 3 episodes of Clostridium difficile Infection (CDI) in the last 9 months, including the current episode
• Not have active irritable bowel syndrome with diarrhea within the previous 24 months
All study-related visits, tests, and medication will be provided to the study patients at no cost. In addition, reimbursement for time and travel may be provided.

How to Enroll in the study?   The ECOSPOR Study is now open for enrollment. It is posted on ClinicalTrials.gov.All the sites which are enrolling patients are listed on clinicaltrials.gov, including contact information for the sites. If a doctor in the study thinks you may be a good candidate, you will be given complete information about the study including everything you should know before you join.  You can also contact clinicalstudies@sereshealth.com to find a doctor near you who is involved in the study.

To LISTEN to Dr. Shelley Trucksis, Ph.D., M.D., and Dr. David Cook, Ph.D. discuss “Ecobiotics- A Novel Approach to Recurrent C. difficile infections”  Click on the Seres Therapeutics Logo below:

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Seres Therapeutics, a leading microbiome therapeutics company, which recently published in the Journal of Infectious Diseases, positive results from an open-label Phase 1b/2 study of SER-109 for the treatment of patients with recurrent C. difficile infections (CDI). Seres Therapeutics is creating a new class of medicines to treat diseases resulting from functional deficiencies in the microbiome, a condition known as dysbiosis. New insights into the human microbiome are fundamentally reshaping how we understand and treat a wide range of diseases, creating new possibilities for patients not served by current therapeutic approaches. Ecobiotics are ecological compositions of beneficial organisms that are designed to reestablish a healthy microbiome. The discovery efforts at Seres Therapeutics currently span metabolic, inflammatory, and infectious diseases. 2016

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summit

Summit Therapeutics  has reported ‘outstanding’ results in the phase II trial of ridinilazole, its new C.difficile infection (CDI) treatment.

During the trial, the new oral antibiotic significantly outperformed vancomycin, the current standard prescription, which was the primary objective said Summit.

Over two-thirds (66.7%) of those treated showed a sustained clinical response (SCR) against 42.4% for vancomycin.

The statistical superiority was driven by a large numerical reduction in recurrent disease compared with vancomycin, which Summit said was key as recurrence is one of the hardest things to stop.

C.difficile or CDI is a growing danger for patients in hospital, care homes and the wider community.

Annually, there are between 450,000 and 700,000 cases in the US alone, with the elderly and sick especially vulnerable.

One study has suggested it costs US $4.8bn to treat these people.

“The healthcare community is acutely aware of the major threat CDI poses, particularly given widespread antibiotic use and our aging population,” said Glyn Edwards, Summit’s chief executive.

The biggest unmet need in CDI treatment is reduce recurring cases, he added and the results from the latest trial had exceeded its ‘wildest expectations’.

“These outstanding clinical data from CoDIFy strongly support the profile of ridinilazole as a narrow spectrum antibiotic.

“There is a vital need for potent new antibiotics, and the potential of ridinilazole has attracted great interest.

Edwards added that the results from the CoDIFy trial were exceptionally encouraging and the aim no is to advance ridinilazole into Phase 3 clinical trials.

Here, the company would evaluate partnership opportunities against the benefit of it forward itself, he added.

Professor Mark Wilcox, at Leeds University and Public Health England’s lead consultant on C.difficile added that the latest data indicated ridinilazole could become an important new treatment option for CDI with the potential to reduce the high rates of recurrent disease that remain a key clinical challenge.

CoDIFy was a double blind, randomised, active controlled, multicentre, Phase II clinical trial that evaluated the efficacy of ridinilazole against vancomycin in 100 patients in the US and Canada.

Results from a second CoFIFy trail are due next year, though Edwards said the results announced today would provide the bulk of the quantitative data.

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

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Rebiotix 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.

Clinical Program
PUNCH™ CD is the name of Rebiotix’s clinical program to assess the safety and efficacy of RBX2660 for the treatment of recurrent Clostridium difficile (C. diff.) infection. It is the most advanced human clinical program evaluating a microbiota-based drug conducted in coordination with the U.S. Food and Drug Administration (FDA) with the goal of developing and commercializing a new therapy to treat patients with recurrent episodes of C. diff. infection. Rebiotix has completed enrollment its PUNCH CD 2 study and continues to assess the safety and efficacy of RBX2660.

PUNCH™ CD 2
Rebiotix has completed enrollment in its PUNCH CD 2 study, a Phase 2B multi-center, randomized, double-blind, placebo-controlled trial to evaluate RBX2660 for the treatment of recurrent C. diff. infection. A total of 117 patients recruited at more than 20 sites in the U.S. and Canada were enrolled in the study, which is the largest randomized controlled study of a MRT for recurrent C. diff. to date.

In this study, the patients received either the microbiota-based drug or a placebo via enema. Neither the doctor nor the patients knew what treatment was received in order to get an unbiased measurement of the drug’s true effectiveness. If a patient’s C. diff. infection symptoms returned, even if they were in the placebo arm of the study, they may have been eligible to receive RBX2660. This is referred to as the open-label portion of the study.

PUNCH™ CD
The PUNCH CD study, which was a Phase 2 open label safety and preliminary efficacy study of RBX2660, was successfully completed in July 2014. An open label study means everyone enrolled in the study got the treatment and it is generally the first phase of a new product development program. The study demonstrated a success rate of 87% for those treated with no serious adverse events related to either the product or the method of delivery.

Product Pipeline
Rebiotix is currently exploring the feasibility of an oral formulation, RBX7455, for the prevention of C. diff.

In addition, Rebiotix is leveraging their years of knowledge and experience to develop MRT applications for other conditions that result from disruption of the gut microbiota.

For more information on Rebiotix and the PUNCH CD and PUNCH CD 2 studies go to:
http://www.rebiotix.com or clinicaltrials.gov.

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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Merck & Co. will file the first antibacterial monoclonal antibody by the end of 2015, the company says.

bezlotoxumab was successful in two Phase III trials against the recurrence of

Clostridium difficile (C. difficile) infection when combined with antibiotics.

Merck plans to file new drug applications for the monoclonal antibody in the US, Canada and EU by the end of the year. Currently, there are no therapies approved for the prevention of recurrent disease caused by C. difficile.

Bezlotoxumab’s approval would also make it the first antibody to treat bacterial infection.

Scientists say mAbs would have benefits over small molecule antibiotics because they are less likely to drive antimicrobial resistance and are administered less frequently. “Results of these studies showed that a single, one-time infusion of the antitoxin bezlotoxumab given with standard of care C. difficile antibiotic treatment significantly reduced the recurrence of C. difficile infection compared to standard of care alone, and demonstrated this benefit over a 12-week period,” said lead investigator Mark Wilcox of the University of Leeds, UK. “These results were also demonstrated in patient subgroups known to be at high risk for C. difficile recurrence.”

C. difficile toxin B can damage the gut wall and cause inflammation, leading to the symptoms of C. difficile enteritis, which include abdominal pain and watery diarrhea. Bezlotoxumab, a fully-human monoclonal antibody, was developed by researchers at the University of Massachusetts Medical School’s MassBiologics Laboratory with Medarex (now part of Bristol-Myers Squibb), and licensed to Merck in 2009.

The studies   Merck’s studies took more than 1,000 patients each and evaluated them over 12 weeks. Participants received either a single infusion of bezlotoxumab, actoxumab (another mAb designed to fight C. difficile),a combination of the two, or a placebo. The actoxumab arm of the study ended early for efficacy and safety reasons.    Both studies had infection recurrence as their primary endpoint – this rate was significantly lower for the bezlotoxumab arms (17.4% and 15.7%) and bezlotoxumab plus actoxumab arms (15.9% and 14.9%), compared to placebos (27.6% and 25.7%). Actoxumab was found not to provide extra benefit on its own or combined with bezlotoxumab, so Merck’s marketing authorisation application is for bezlotoxumab alone.

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To Listen to the Podcast — MERCK’s Dr. Nicholas Kartsonis discusses the many contributions of Merck and ongoing research addressing CDI  — and  the history in addressing infectious disease and antimicrobial resistance. Dr. Nick Kartsonis also  discusses the future in the area of C. diff. and some of the company’s current treatments, including DIFICID and their ongoing research addressing CDI  Click on the MERCK Logo Above *

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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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XBiotech is a biotech company located in Austin, Texas and was founded on the concept of the “True Human Antibody”.  Antibodies are specialized proteins, which are produced by the immune system.  Their function is to bind to a very specific target, such as a virus or bacteria, and aid in the elimination of these targets by the immune system.  Monoclonal antibodies were developed as a class of drug, which use the specific targeting function of the antibody to target substances that cause disease. Currently approved monoclonal antibodies however, are developed in the laboratory or in mice.  XBiotech’s approach is to isolate antibodies that are present naturally in healthy human donors, and develop these into products that can be used to treat disease.  We believe that antibodies isolated from humans, will be safer and will function better than so called antibodies marketed as “fully human”, which are in fact engineered.

Over the past decade, Clostridium difficile (C. diff) has emerged as a significant public health threat.  In fact, the CDC has designated it as an “Urgent threat level.”

In October 2015, XBiotech announced it had set out to develop a first-in-class oral monoclonal antibody against C. diff infection. Just two weeks after this announcement, the Company reported it had already identified positive blood samples for anti-clostridium difficile antibodies after screening blood donations from healthy volunteers.

XBiotech’s plans to develop an antibody therapy that directly targets and neutralizes the bacteria. The Company intends to deliver the therapy orally, targeting C. diff in the gastrointestinal tract, where the antibody could reduce the bacteria’s ability to establish debilitating or life threatening infections.

XBiotech

Click on the XBiotech LOGO to the left  to listen to the February 2016  XBiotech Podcast which introduces XBiotech, developer of True Human(TM) therapeutic antibodies. XBiotech has an exciting pipeline of product candidates in various areas of medicine. The Company recently announced the launch of a research and development program to develop a first-in-class oral monoclonal antibody against Clostridium difficile (C.difficile) infection. The Company will discuss the need for an effective C.difficile therapy, their novel approach to treating the disease as well as efficiency in their manufacturing technology. Join guests: Dr. Michael Stecher, Medical Director, Dr. Sushma Shivaswamy, Vice President of Research and Development, and Kelly Thornburg, Senior Vice President of Operations, as they discuss how XBiotech is pioneering a new era in the discovery and development of targeted antibodies therapeutics.

For more information please contact the Company by emailing info@xbiotech.com or calling 512-386-2900.    www.xbiotech.com

C. diff. Spores and More – CdiffRadio – Welcomes Guests; Dr. Guy de Bruyn,MD, Dr. Christian Felter,MD, and Dr. Patricia J. Pietrobon,Ph.D. of Sanofi Pasteur

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Join us on Tuesday, March 1st as we discuss ——-

C. diff. Vaccine Update; Sanofi Pasteur’s Cdiffense”

Tuesday, March 1st — Live Broadcast Times

10 a.m. Pacific Time,,   11 a.m. Mountain Time,
12 p.m. Central Time,    1 p.m. Eastern Time

We invite you to  listen to the live broadcast and archived programs by clicking on the
Cdiff radio logo displayed below:

cdiffRadioLogoMarch2015

This episode we will introduce  Sanofi Pasteur, one of the leading vaccine manufacturers in the world, is in the midst of its Phase III clinical trial called Cdiffense to study its investigational vaccine to prevent Clostridium difficile infection (CDI).

The trial is now in more than 20 countries across 5 continents to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary, symptomatic CDI.

The investigational C. diff vaccine is designed to produce an immune response that targets the toxins generated by C. diff bacteria, which can cause inflammation of the gut. The investigative vaccine ultimately may help prevent a future infection from occurring. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization or have had at least two hospital stays and have received systemic antibiotics in the past year.

For more information on the Cdiffense trial – Please visit www.Cdiffense.org 

Join Guests: 
Dr. Guy de Bruyn, MD  –  Director for Clinical Development at Sanofi Pasteur, overseeing a large phase III vaccine trial for the prevention of Clostridium difficile infection in some 19 countries on 5 continents around the world that started in the U.S. in 2013.

Dr. Christian Felter, MD  –  Associate VP, Global Medical Expert for Nosocomial Vaccines for Sanofi Pasteur based in Lyon, France. His focus is on their investigative Clostridium difficile vaccine. Dr. Felter has 11 years of experience in medical affairs roles in the US and Europe, covering therapeutic areas including Immunology, Rheumatology, and Infectious Diseases.

Dr. Patricia J. Freda Pietrobon, PhD  – Associate Vice President, Research & Development Sanofi Pasteur Dr. Patricia J. Freda Pietrobon, PhD, Associate Vice President, R&D, Sanofi Pasteur, has over 25 years of experience in the Vaccine & Diagnostic industries and more then 20 years in leadership roles focusing on research & development of new vaccines.

Join us as we introduce Sanofi Pasteur and discuss updates focused on

C. diff. Vaccine Update; Sanofi Pasteur’s Cdiffense

C. diff. Spores and More™  Global Broadcasting Network –  producing educational programs dedicated to  C. difficile Infections and more —  brought to you by VoiceAmerica and sponsored by Clorox Healthcare

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

Japan Joins The Phase III Cdiffense Trial Of Investigational Clostridium difficile Vaccine

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Cdiffense trial to evaluate vaccine against a leading cause of life-threatening

The Following is a Press Released Produced By Sanofi Pasteur

January 7, 2016:  Tokyo, Japan – Sanofi K.K. Headquarters; Shinjuku-ku, Tokyo: President: Fabrice Baschiera announced on January 7th, 2016 that Sanofi Pasteur; the vaccines division of Sanofi, started the initiation of its Phase III clinical program in Japan called Cdiffense to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of symptomatic Clostridium difficile infection (CDI).  Clostridium difficile (C. diff. ) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease.

The risk of CDI increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks.  The investigational vaccine is designed to help protect at-risk individuals from CDI, which is emerging as a leading cause of life-threatening ,  healthcare-associated infections (HAI’s) worldwide.

Since 20 to 30 percent of patients experience recurrances of CDI, re-hospitalizations and longer hospital stays remain common (2)  Although relatively few studies on C. difficile have been performed in Asia, what work has been done demonstrates that CDI is a significant cause of nosocomial disease in Asian countries. (3).

Sanofi Pasteur’s investigational C. diff. vaccine is designed to produce an immune response that targets the toxins generated by C. diff. bacteria, which can cause inflammation of the gut and lead to diarrhea.  The phase III clinical trial is designed to determine if the investigational vaccine will help prevent a future infection from occurring.

“With an increased focus on surveillance, we are learning more about the frequency, severity, and cost of C. diff. infections in Japan.  Prevention and control through vaccination represents an opportunity to protect patients and reduce healthcare costs associated with C. diff.” explained Michael Mullette, Corporate Office, at Sanofi Pasteur.

The Cdiffense Phase III clinical program has just started recruiting volunteers in Japan for a randomized, obsserver-blind, placebo-controlled, multi-center, multi-national trial that will include up to 15,000 adults at 200 sites across 20+ countries.  Volunteers for the study should be age 50 or older and are planning an upcoming hospitalization, or have been in the hospital and received systemic antibiotics in the past year.  For more information on the Cdiffense trial, please visit http://www.Cdiffense.org

 

About C. diff.

Clostridium difficile (C. diff. ) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease (infection).  A main source of C. diff. is infected patients who release spores into the environment that can then infect other people (hand to mouth route *)

When antibiotics disrupt the gut’s normal flora and a person ingests C. diff. spores, the C. diff. bacteria multiply and proliferate into the colon* and then release potent toxins that cause the C. difficile symptoms and damage a person’s intestinal lining.

*Mode of transmission of CDI can be either directly or indirectly, hospital acquired (nosocomial) or community – acquired; Ingesting C Diff spores transmitted from others and patients by hands, or altered normal intestinal flora by antibiotic therapy allowing proliferation of C Diff in the colon.  Coming in contact with surfaces, devices, or material with Clostridium difficile spores can easily be transferred to individuals by hands that have touched a contaminated surface or item. Examples of surfaces, devices, and materials contaminated with C Diff spores in hospital and community/outpatient settings: commodes, bath tubs, showers, hand rails, bed rails, counter tops, handles, clothing, medical equipment. *

About Sanofi Pasteur:

Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients’ needs.  Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme.  Sanofi is listed in Paris (EURONEXT:SAN) and in New York (NYSE:SNY).

Sanofi Pasteur; the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe.  A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases.  the company’s heritage to create vaccines that protect life, dates back more than a century.  Sanofi Pasteur is the largest company entirely dedicated to vaccines.  Every day, the company invests more than EUR 1 million in research and development.  For more information please visit http://www.sanofipasteur.com

or http://www.sanofipasteur.ip

Resources:

1 Center of Disease Control and Prevention, Frequently Asked Questions about Clostridium difficile for Healthcare Providers, Centers for Disease Control and Prevention  http://www.cdc.gov/HAI/organism/cdiff/Cdiff_faqs_HCP.html

2  Garey KW, et al (2006) Mete-analysis to assess risk factors for recurrent Clostridium difficile infection, Journal Hospital Infection, 70 p , 206-304

3.  Collins et al. Antimicrobial Resistance and Infection Control 2013, 2-21; http://www.aricjournal.com/content2/1/21

* Clostridium difficile (CDI) Infections thttp://www.cdc.gov/hai/pdfs/toolkits/CDItoolkitwhite_clearance_edits.pdf

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

 

Allegheny General Hospital (AGH) Enrolls Patients In a Clinical Study Of Investigational Vaccine for Prevention Of Leading Healthcare-Associated Infection; Clostridium difficile

Allegheny General Hospital (AGH), part of Allegheny Health Network, announced that it will enroll patients in a clinical study to evaluate the safety and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile infection (CDI).

Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. While most types of healthcare-associated infections (HAIs) are declining, C. diff is emerging as a leading cause of life-threatening, HAIs worldwide. The infection poses the greatest danger for older adults in hospitals or long-term care facilities who take broad-spectrum antibiotics.

Allegheny General joins more than 200 sites across 17 countries around the world in the Cdiffense clinical trial, a Phase III randomized, observer-blind, placebo-controlled study. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization of more than 72 hours for a surgical procedure. People in this age group who have had at least two hospital stays, each lasting more than 24 hours, and have received systemic antibiotics in the past year are also eligible.

“With the emergence of difficult-to-manage strains of C. diff, CDI has become more frequent, more severe and more difficult to treat in recent years, raising concerns about how to control it and prevent transmission,” explained Zaw Min, MD, an infectious disease specialist who is serving as principal investigator of the trial at AGH. “Vaccination could be an efficacious, cost-effective and important public health measure to protect individuals from C. diff.”

For more information, contact:

 

For more information about the Cdiffense Phase III clinical trial, please contact AGH’s study coordinator at 412.359.3095 or visit www.Cdiffense.org

Utah doctor seeks patients to test vaccine to prevent C. diff. Infection (CDI)

The clinical trial being offered by Dr. Derek Muse, a medical director for Jean Brown Research  https://www.jeanbrownresearch.com/studies/c-diff-vaccine-study/

aims to test a vaccine not yet approved by the FDA that contains inactivated toxins that are produced by the bacteria, helping to cause immunity in the bloodstream.

For more information or to enroll in the C. diff vaccine study, visit www.cdiffense.org.

C. diff has been called an “urgent threat to the public,” causing an estimated half-million infections and at least 29,000 deaths in the United States in 2011, according to the U.S. Centers for Disease Control and Prevention. Rates of infection increased 400 percent from 2000 to 2007, as more dangerous strains emerged and it has become more difficult to treat.

Clostridium difficile is a bacteria found in feces. People taking antibiotics increases the risks are more prone to picking it up, transmitting it from hand to mouth, as many of a person’s protective measures are depleted during antibiotic treatment.  C. diff. infections are also community acquired.

Dr. Muse said about half of the cases of C. diff occur in people younger than 65, but those in people age 65 and older remain in the high risk category and account for 95 percent of deaths related to the infection.

Symptoms include diarrhea, fever, nausea and other abdominal issues that can lead to a perforated colon and bacteria leaking into the bloodstream.

With this vaccine, we’re trying to reduce the chances they’d come down with this potentially virulent infection,” Muse said.

People most at risk for developing the infection include anyone who takes antibiotics, which includes patients who are hospitalized for any number of reasons, as well as those who are scheduled for various surgeries.

The clinical trial being offered by Dr. Muse, a medical director for Jean Brown Research, aims to test a vaccine not yet approved by the FDA that contains inactivated toxins that are produced by the bacteria, helping to cause immunity in the bloodstream.

“Our hope is that they’d be protected for their lifetime, but we just don’t know that yet,” Muse said. “It’s something that would be evaluated by the results of the trial.”

The trial, sponsored by global pharmaceutical company SanofiPasteur, needs 15,000 enrollees across 20 countries throughout the world to reach statistical significance. The company has successfully developed vaccines for tetanus, typhoid, pertussis, rabies and more. It also manufactures the influenza vaccine most commonly used in the market today.

***  To be eligible for the clinical trial to evaluate effectiveness against C. diff, patients *must be age 50 or older
*hospitalized twice in the past year for 24 hours or more
*and/or planning to have an upcoming surgical procedure.

Dr. Muse said the study doesn’t guarantee participants will receive the active vaccination, as placebos are used to confirm the research.

“We’re trying to bring very helpful medications to the market and that requires a lot of volunteers,” he said. “In the end, we ask patients to sacrifice a little bit of their time to participate in these studies and some medications end up saving millions of lives all over the world.”

A number of vaccines come out each year, including one for meningitis that became available earlier this year. An update of the human papillomavirus vaccination, as well as one to help the elderly avoid pneumonia are also newly available.

“These things cause so much suffering,” Muse said. “Doctors want these vaccines yesterday.”

Muse blames over-prescription of antibiotics for the growing number of cases of C. diff. Antibiotics, he said, can destroy the normal bacteria in the intestine, which can result in overgrowth of toxic spores that can injure the lining of the colon and cause diarrhea, abdominal pain and bloody stool.

The key, he said, is preventing C. diff altogether.

Antibiotic Use:  “Talk with your doctor whether you really need an antibiotic or not,” Muse said. “Many upper respiratory infections don’t need antibiotic treatment. Even mild sinus infections don’t have to be treated.”

*Utilize natural remedies when treating symptoms caused by viruses and discuss over the counter medications and alternatives available with the healthcare provider.

Antibiotics, unless necessary, should be deferred or delayed until necessary

For more information or to enroll in the C. diff vaccine study, visit www.cdiffense.org.

 

To read the article in its entirety click on the following link:

http://www.deseretnews.com/article/865636216/Utah-doctor-seeking-patients-to-test-vaccine-to-prevent-potentially-debilitating-infection.html

Sanofi Pasteur Discusses Developing a Preventative C.diff. Infection Vaccine March 17, 2015 with C Diff Foundation’s ‘C diff Spores and More’ #CdiffRadio

cdiffRadioLogoMarch2015C. diff. Spores and More”

We invite you to join us in listening to this exciting episode on March 17th, 2015 and every Tuesday at the following times:

11a – 12p PT, 12p – 1pm MT, 1 pm – 2 pm CT,                              2 pm – 3 pm ET

 

Sanofi Pasteur, one of the leading vaccine manufacturers in the world, is currently conducting a Phase III clinical trial called Cdiffense in more than 20 countries across 5 continents to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary, symptomatic Clostridium difficile infection (CDI). The Cdiffense Phase III clinical program hopes to recruit up to 15,000 adults over 200 sites across the 20+ countries.

SANOFI Pasteur - RVB - Colors[1]Sanofi Pasteur’s Dr. Christian Felter, MD is Associate VP, Global Medical Expert for Nosocomial Vaccines for Sanofi Pasteur based in Lyon, France. His focus is on their investigative Clostridium difficile vaccine.

Dr. Patricia J. Freda Pietrobon, PhD, Associate Vice President, R&D, Sanofi Pasteur, has over 25 years of experience in the Vaccine & Diagnostic industries and more then 20 years in leadership roles focusing on research & development of new vaccines.

Dr. Guy de Bruyn, Director for Clinical Development at Sanofi Pasteur, overseeing a large phase III vaccine trial for the prevention of Clostridium difficile infection in some 19 countries on 5 continents around the world that started in the U.S. in 2013.

Listen in on March 17th  as these three  Sanofi Pasteur professionals discuss the background of acquiring a C.difficile infection,  Sanofi Pasteur’s Phase III clinical trial called Cdiffense,  and data from the preventative vaccine in Phase II

Click on the link below to access the C. diff. Spores and More Show Page:

www.voiceamerica.com/show/2441/c-diff-spores-and-more

 

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Cdiffense – Sanofi Pasteur’s Clinical Vaccine Trial for C. diff. Prevention Now in Phase III

Sanofi Pasteur’s Clinical Vaccine Trial for Prevention of C.diff Now in Phase III Stage

Sanofi Pasteur, one of the world’s largest vaccine manufacturers, is developing a vaccine for prevention of Clostridium difficile.

Because of the unmet medical need regarding this disease, in 2010, The U.S. Food and Drug Administration (FDA) granted fast-track designation to Sanofi Pasteur’s investigational Clostridium difficile vaccine candidate. The vaccine is now in the Phase III stages of its Clinical Vaccine Trial and is looking for volunteers in several countries to participate in this preventative vaccine trial.

For more information regarding the Cdiffense Cdiff vaccine trial and trial centers, please visit http://www.cdiffense.org