Tag Archives: Healthcare-Associated Infections

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.

Loyola Int’l C. diff. Research, Dr. Dale Gerding, MD Makes Important Breakthrough Towards the Prevention of Recurring C.diff. Infection

In what is a major step towards the prevention of recurring bouts of Clostridium difficile (C.diff.) infection, an international team led by Dr. Dale Gerding, MD, Hines Veterans Administration (VA) research physician and professor of Medicine at Loyola University Chicago Stritch School of Medicine, has shown that giving spores of non-toxic C.diff. by mouth is effective in stopping repeated bouts of C.diff. infection which occurs in 25-30 percent of patients who suffer an initial episode of diarrhea or colitis.

 

The study is published in the May 5 issue of the Journal of American Medical Association (JAMA) and is the focus of a JAMA-produced video.

“The results of this study are very gratifying because the preclinical laboratory and patient studies were all done through our VA research program supported by the Department of Veterans Affairs Research Service,” says Gerding. “Results of this study confirm findings of earlier studies that showed that if we can establish non-toxic C.diff. as a resident of the gut of the patient, that we can protect the patient from infection by the toxic strains of C.diff..” Viropharma and Shire pharmaceutical companies supported the clinical trials.

These results warrant additional study to confirm that treatment with non-toxic C.diff. spores can reduce recurrent C.diff. infection and prevent a first episode of C.diff. infection in those who are taking any antibiotics and are at high risk of infection, he added.

Gerding and an international team of infectious disease researchers, including those at Loyola University Medical Center (LUMC), randomly assigned 168 adult patients with C.diff. infection who had been treated for their infection with antibiotics to receive doses of 10 thousand or 10 million spores per day of non-toxic C.diff. in liquid form for 7 or 14 days, or to receive an identical placebo. Of those assigned any dose of non-toxic C.diff. , 11 percent experienced a repeat of infection within 42 days compared with 30 percent of those given a placebo, a statistically significant reduction. For the most favorable dose tested, 10 million spores a day for 7 days, the recurrence of C.diff. infection was reduced to 5 percent.

Healthcare-acquired infections (HAI) including a leading HAI, C.diff. causes severe diarrhea and inflammation of the lower bowel or colon, continues to escalate in frequency and severity in the U.S.

According to the Centers for Disease Control and Prevention (CDC) report published in
February 2015, almost 500,000 C.diff. infections occurred in the U.S. in 2011, with 83,000 recurrences and 29,000 deaths within 30 days of diagnosis.  Older adults taking antibiotics and who receive care at medical institutions have a higher risk at acquiring this infection.

Cheryl O’Riordan, who has had repeated bouts of C.diff. infection, said having C.diff. made her visit the bathroom on an average of 10 times per day. “Before receiving effective treatment, I was unable to leave the house,” says the active cyclist, skier and hiker. O’Riordan went into remission after being treated successfully at LUMC. “I am back cycling more than 3 miles every day and have several major adventure trips planned.”

Gerding, who has published more than 135 studies on C.diff. is considered one of the leading international experts on C.diff..

Stuart Johnson, MD, infectious disease specialist at LUMC, is also the director of research at Hines VA hospital. Together Gerding and Johnson have partnered on C.diff. research for almost three decades, involving many LUMC patients.

“The study offers real hope for those debilitated by recurring bouts of C.diff.,” says Johnson “This study represents a novel and potentially highly effective bacteriotherapy approach to restoring colonization resistance against toxic strains of C.diff. in these patients,” he adds.

Loyola University Health System is recognized internationally as a leader in infection control and prevention.

LUMC is one of a few select hospitals who invest in universal screening of all inpatients for MRSA. Loyola was one of the first institutions to require all staff to have mandatory flu shots as a condition of employment. Loyola was one of several academic hospitals that participated in this recent benchmark international study.

 

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

http://www.eurekalert.org/pub_releases/2015-05/luhs-lso050115.php

WHO Healthcare-Associated Infection Pledge 2015


C Diff Foundation Pledges Continued Support to Reduce Healthcare-Associated Infections
The C Diff Foundation continues to recognize the serious disease burden and significant economic impact that healthcare-associated infections places on patients and the health care systems throughout the world.

 

Considering that the majority of these infections are treatable and preventable, appreciating the momentum that the Global Patient Safety Challenge program of the WHO World Alliance for Patient Safety is bringing to reduce healthcare-associated infection at the global level.
Emphasizing that a unique opportunity exists to reverse the incidence of healthcare-associated infections, members of the C Diff Foundation shares and pledges……..
To work together to witness a reduction in healthcare–associated infections through the following actions:
• Acknowledging the importance of healthcare-associated infections;
• Developing or expanding ongoing campaigns at national or sub-national levels to promote and improve hand-washing (aka hand hygiene) methods among health care providers;
• Making reliable and validated information available on healthcare-associated infections at community and district levels to foster appropriate actions;
• Sharing experiences and, where appropriate, available surveillance data, with the WHO World Alliance for Patient Safety;
• Consider the use of WHO strategies and guidelines to tackle healthcare-associated infection, in particular in the areas of hand-washing (aka hand hygiene), raise awareness of antibiotic stewardship, and environmental procedure safety.

We will work with health professionals and associations worldwide:
-To promote the highest standards of practice and behavior to reduce the risks of healthcare-associated infection;
-To foster and sustain collaboration with research institutions, training schools, educational centers, universities, healthcare settings, and agencies of other WHO Member States to ensure full utilization of knowledge and experience in the field of healthcare-associated infection.
-To encourage senior management support and role-modeling from key staff to promote the implementation of interventions to reduce healthcare-associated infections.
C Diff Foundation
May 5, 2015

 

For more information about Clean Care is Safer Care, please contact the team at savelives@who.int

 

What you need to know about C. diff. and High Touch Surfaces discussed on C. diff. Spores and More on April 28th with Bradley Whitchurch CEO Seal Shield, Dr. Rosie Lyles, MD Clorox Healthcare, and Shelby Lassiter, BSN,RN,CPHO,CIC Infection Preventionist

What you need to know about C. diff. and high touch surfaces

Join us on Tuesday, April 28th at 11:00 a.m. Pacific
time – 2 p.m. Eastern Time with our three guests…………

 

 

 

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

 

Bradley Whitchurch, Founder and Chairman of the Board at Seal Shield, LLC,
Dr. Rosie D. Lyles, MD, Clinical Affairs Head, Research and Department, Clorox Healthcare and Shelby Lassiter, BSN, RN, CPHO, CIC, Infection Preventionist at a University Hospital in North Carolina,.

Listen in as these three professionals come together to discuss C. diff. infections,
healthcare-associated infections, and you will want to learn why hand hygiene alone is not enough.  Plus discussions about infection prevention measures being utilized in healthcare and home settings to keep everyone safe.

Guest Bio’s:

Bradley Whitchurch
Brad is the Founder, CEO and Chairman of the Board at Seal Shield LLC. Seal Shield is an infection control solutions manufacturer headquartered in Jacksonville, FL. The Company produces waterproof, antimicrobial input devices for healthcare and other global markets. Seal Shield’s primary products include washable, antimicrobial keyboards, mice and TV remote controls. Mr. Whitchurch has been a pioneer in the computer products industry for 25 years.

Dr Rosie Lyles MD
Dr. Lyles is Currently the Clinical Affairs Head, Research and Department, Clorox Healthcare and serves as the primary liaison for Client’s Healthcare division as a department head to relevant professional, research and academic institutions, public health agencies, and forums. The role will provide strategic guidance and assist with the development and implementation of a plan for clinical/scientific support of marketing initiatives. This includes overall responsibility for public health message development, publication planning, key opinion leader development and provides relevant input into the clinical and product intervention design and development.

Shelby Lassiter, BSN,RN,CPHQ,CIC
Shelby holds an Associate Degree in Nursing from Wake Technical College and a Bachelor’s Degree in Nursing from East Carolina University. She is certified in Infection Control (CIC) and is a Certified Professional in Healthcare Quality (CPHQ) through the National Association of Healthcare Quality (NAHQ). She has over thirty-five years of experience in healthcare: medical/surgical nursing, critical care, healthcare quality and infection prevention. Shelby has held a variety of positions in Infection Prevention and is currently an Infection Preventionist at a University Hospital located in North Carolina.

Synthetic Biologics Discuss Preventing C. diff. Infection with SYN-004 on “C diff Spores and More,” C. diff. Radio

 

Join us on Tuesday, March 31st at 11:00 a.m. Pacific, 1 p.m. Central, 2 p.m. Eastern Time for the live broadcast –  Synthetic Biologics: Preventing C. diff. Infection with SYN-004

 

 

 

Synthetic Biologic, Inc.’s  Lewis Barrett, BS, MBA, Senior Vice President, Commercial Strategy and Dr. Joseph A. Sliman, MD, MPH, Senior Vice President, Clinical & Regulatory Affairs will discuss the novel point-of-care preventive approach, the clinical development pathway and the potential of the Company’s lead pathogen-specific product candidate, SYN-004.

 

For direct access to the “C. diff. Spores and More Program” please click on the link below:

http://www.voiceamerica.com/episode/84381/synthetic-biologics-preventing-c-diff-infection-with-syn-004

 

The majority of C. difficile cases are caused by the unintended consequences of antibiotic therapy to the gut microbiome. Intravenous (IV) antibiotics excreted to the gut often wipe out the natural balance of microflora, which can lead to recurring diarrhea and perforation of the intestinal wall, with potentially fatal outcomes. Co-administered with IV
antibiotics, Synthetic Biologics’ product candidate, SYN-004, is designed to be a preventive therapy intended to protect the gut microbiome by degrading IV antibiotics, thereby preventing the onset  of  a C. difficile infection.
Synthetic Biologics, Inc. (NYSE MKT:SYN)

http://www.syntheticbiologics.com

 

 

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