Tag Archives: C Diff Clinical Trials

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

Breaking News in Treatment of Recurrent C. difficile Infection : Rebiotix, Inc. Receives Breakthrough Therapy Designation for Microbiota Restoration Therapy RBX2660 by U.S. Food and Drug Administration

Rebiotix Receives Breakthrough Therapy Designation for RBX2660A Microbiota Restoration Therapy (MRT) for the Treatment of Recurrent Clostridium difficile Infection

Milestone reinforces Rebiotix as a leader in microbiota-based drug development and product commercialization

Rebiotix Inc. announced that U.S. Food and Drug Administration (FDA) has designated its lead Microbiota Restoration Therapy (MRT) RBX2660 as a Breakthrough Therapy for the treatment of recurrent Clostridium difficile (C diff) infection, a challenging to treat gastrointestinal (GI) infection that causes 29,000 deaths in the U.S. annually.

Rebiotix is a clinical stage biotechnology company that was founded to revolutionize the treatment of debilitating GI diseases by harnessing the power of the human microbiome. MRT is the Rebiotix drug platform for delivering healthy, live, human-derived microbes into a sick patient’s intestinal tract to treat disease.

Studies have shown that most cases of C diff infection occur after the normal microorganisms that reside in the gut have been disrupted by antibiotic use. Restoring the balance of microbes is thought to be key to breaking the cycle of recurrence. Lead Rebiotix product, RBX2660, is targeted at treating recurrent C diff.

“The development of RBX2660 represents our commitment to harnessing the microbiome to develop therapies for debilitating and sometimes fatal disease for which there is currently no FDA-approved alternative,” said Rebiotix CEO Lee Jones. “The Breakthrough Therapy Designation marks the third regulatory milestone for our lead product, RBX2660, in the past two years, and reinforces our leading efforts that have brought us to the cusp of delivering a revolutionary and validated treatment to patients living with recurrent C diff.”

About the Breakthrough Therapy Designation

According to the FDA, Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). For more information please visit http://www.fda.gov/forpatients/approvals/fast/ucm405397.htm.

10/12/2015

For additional Information click on the following link:
http://rebiotix.com/index.php/rebiotix-receives-breakthrough-therapy-designation-for-rbx2660-recurrent-c-diff?utm_campaign=Breakthrough&utm_medium=Social-Media&utm_source=Twitter&utm_content=FDA&utm_term=Press

 

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

 

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

C. diff. In the News – New Antibiotic Could Treat C. diff. In Time

Access article/video in its entirety by clicking on the following link:

http://www.bbc.com/news/uk-scotland-34106754

New antibiotic could transform C. diff treatment

Clinical trials have begun of a treatment that could fight outbreaks of the bacterial infection Clostridium difficile.

Scientists at Strathclyde University (Scotland), who developed the antibiotic, say it is the first of a new class of drug that could transform the treatment of potentially fatal diseases.

 

 

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

C. diff. Infection Prevention Study: Phase 2 Study SER-109 by Seres Therapeutics; First Patient Dosed for the Prevention of Recurrent C. diff. Infection in Adults

* In The News *

Seres Therapeutics, Inc., a leading microbiome therapeutics platform company, announced on May 28th, 2015 the enrollment and dosing of the first patient in its Phase 2 clinical study of SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (CDI) in adults.

The objective of the Phase 2 study is to further assess the efficacy and safety of SER-109, Seres’ leading development candidate.

“Recurrent CDI is a rapidly growing problem in the U.S., and antibiotics are currently the only FDA-approved treatment option,” said Roger Pomerantz, Chairman, President and CEO of Seres. “For many patients, antibiotics may exacerbate the problem by inducing or prolonging an imbalance of the microbiome and creating the conditions that support disease recurrence. We are excited about evaluating the potential of SER-109 to correct the microbiome and address this critical patient need.

“The start of our Phase 2 study is an important milestone for patients, and for Seres.

Our earlier studies suggest that SER-109 is a potentially transformative therapeutic for tens of thousands of patients each year, validating our conviction that treating dysbiosis of the microbiome enables us to address the underlying cause of disease and bring about rapid improvements in health.”

Results from the Phase 1b/2 study of SER-109 in recurrent CDI patients showed that 87 percent of patients met the primary study endpoint and 97 percent of patients achieved a clinical cure, which was defined as the absence of CDI requiring antibiotic treatment during the eight-week period after SER-109 dosing.

The Phase 2 study is a multicenter, randomized, placebo-controlled study that will evaluate the efficacy and safety of SER-109. The primary outcome measure is the absence of clinically-significant CDI through eight weeks following administration of SER-109 compared to placebo. SER-109 will be administered orally as a single dose, following the standard of care antibiotics for CDI. The study is actively enrolling and will be conducted at approximately 35 centers across the U.S. The read-out from the Phase 2 study is currently expected in the middle of 2016.

About SER-109

SER-109 is the lead Seres Ecobiotic® microbiome therapeutic in clinical testing for the treatment of recurrent Clostridium difficile infection (CDI). SER-109 was developed utilizing the Seres Microbiome Therapeutics platform that provides deep insight into the ecologies of disease and then identifies microbial compositions that can catalyze a shift to health. CDI is a rapidly growing problem associated with antibiotic use. Approximately 85,000 to 110,000 CDI patients in the U.S. are expected to have more than one recurrence.

About Seres Therapeutics, Inc.

Seres Therapeutics, Inc. is a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome.

 

For article in its entirety:

http://finance.yahoo.com/news/seres-therapeutics-inc-announces-first-113000601.html

 

 

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