Tag Archives: Clostridium difficile

Zinplava has been launched by MSD in the UK

MSD has launched Zinplava in the UK, offering patients a novel therapeutic option for the prevention of Clostridium difficile recurrence.

Zinplava (bezlotoxumab) is not an antibacterial and is not indicated to actually treat the infection, but is a monoclonal antibody designed to neutralise C. difficile toxin B, which can damage the gut wall and cause inflammation, leading to diarrhoea.

It is the first and only EC licensed non-antibiotic option indicated to prevent recurrence of Clostridium difficile infection (CDI) in high-risk adults.

Around one-in-four patients experience a recurrence after the initial episode, and more than 40 percent of these have further recurrence, highlighting the need for new options able to break the infection cycle.

Pivotal Phase III clinical studies showed the rate of infection recurrence through week 12 to be significantly lower in patients given Zinplava (17.4 percent and 15.7 percent) or Zinplava and actoxumab (15.9 percent and 14.9 percent) than those taking a placebo (27.6 percent) and (25.7 percent), respectively.

“Notably, bezlotoxumab reduces the risk of the recurrence of CDI for at least 3 months, compared with standard of care antibiotic therapy. This is welcome addition to our limited options to reduce the considerable morbidity and mortality associated with CDI,” commented Mark Wilcox, Professor of Medical Microbiology at the University of Leeds.

“Antimicrobial resistance is a key national issue and we hope with bezlotoxumab to not only help achieve a reduction in the number of recurrent episodes of CDI but also a reduction in the amount of antibiotic prescriptions that would otherwise be needed to treat these recurrent episodes,” added Dr Mike England, MSD’s Interim Medical Director.

Zinplava is administered as a single, one-off, one-hour intravenous infusion alongside standard-of-care antibiotic therapy for the treatment of CDI.

 

C Diff Foundation and C diff Survivors Alliance Network Share a Winter 2017 Bulletin

Greetings from the main office of the C Diff Foundation and the C diff Survivors Alliance Network located in New Port Richey, Florida.  As we close 2017 we mark the 5th anniversary of the two organizations. We want to share with you a summary and reflection on this year’s events and campaigns moving our mission forward and message delivered worldwide. The mission and promoting C.diff. Awareness has been shared this year with  listeners in over 25 Counties during Season III on C. diff. Spores and More Global Broadcasting Network (www.cdiffradio.com),  5,000+ visitors during global events, 9,600+ residents and business owners throughout villages and communities by our dedicated volunteer patient advocates, to over 1,000 clinicians who received up-to-date data expanding their knowledge during workshops and local symposiums offered worldwide, 3,000+ incoming calls received through the Nationwide Hot-Line 1-844-FOR-CDIF with the thousands of e-mails received seeking assistance.

After each event, workshop, meeting, introduction we thank the individuals for sharing  in five years of opportunity to provide life-saving data educating and advocating for C. difficile infection prevention, treatments, environmental safety and support worldwide.  The mission of the C Diff Foundation is the momentum of charity that has proven effective and grown over the past five years.  A single act of charity grows into more and greater charity worldwide.  The work each member of the C Diff Foundation, with hundreds of Volunteer Patient Advocates, promote the Foundation’s mission which never stops with a single act.  Instead, it builds, it grows, and it expands into an exponential impact of good in the world helping to save lives.  We thank you for your continued support and encourage you to continue your journey, proposing three verbs important to the C Diff Foundation and the C diff Survivors Alliance Network in general.

The first of these verbs is “to promote” C.diff. Awareness. It is the first step that opens doors in educating individuals, clinicians, communities in learning more about this life-threatening infection which causes a great amount of pain and suffering around the globe.  It is essential and it is the compass in reaching shared goals.

The second verb is “to heighten awareness” across the nation to continue proclaiming November Clostridium difficile infection awareness month. The Governors proclaimed November C. difficile (C.diff) infection awareness month in 2017 and we encourage them “to welcome” this proclamation in 2018 with more than a yearly executive order of greeting or inviting their residents to take notice.  We look forward to working with delegates, with your support, to make this proclamation statement nationwide and welcome the importance of the time, education, programs, and agenda in place addressing this life-threatening infection.  The C Diff Foundation advocates and supports the individuals and families suffering during and after being treated for a C. diff. infection.

Finally, the third verb that the C Diff Foundation and C diff Survivors Alliance Network propose is “to go.”  Here we are all challenged to do something big or small — with what we are able to do.  With the unity of members with volunteers with patients, families, and clinicians we can make a difference with enthusiasm and simplicity to get up and go.  We can do for others  today what we could not do for ourselves during our time of illnesses, during the long periods of isolation, during the losses, and during the pain and suffering.

As members of the C Diff Foundation we know that our enthusiasm  for our mission is the desire to bring awareness and promote C. difficile infection prevention, treatments, environmental safety and support worldwide.  We witness changes by the data and information being delivered within villages,  through major cities and in small communities — it is only by taking this path that we gain satisfaction knowing that the news delivered with enthusiasm “to promote, to heighten awareness and to go” with the members and volunteers in the C Diff Foundation and C diff Survivors Alliance Network creates positive results.

We are truly grateful for your continued dedication, efforts and support and thank you again for making this year’s November anniversary such a special occasion through the growth and advances made worldwide.   Let’s carry the mission into the New Year, carving new paths to witness the decline of newly diagnosed cases of Clostridium difficile (C.diff., C. difficile) infections and saving lives worldwide.

“None of us can do this alone ~ All of us can do this together.”

 

 

Rebiotix Announces Expansion of Phase 1 Study For Prevention of Recurrent C.diff. Infection Oral Capsule Microbiota Product RBX7455

Rebiotix Announces Expansion of Phase 1 Trial of the Company’s Oral
Capsule Microbiota Product, RBX7455, Following Successful Completion of
Initial Study Arms

Additional cohorts to examine potential of reduced dosing regimens of RBX7455 for the prevention of recurrent Clostridium difficile infection

Rebiotix Inc., a clinical-stage microbiome company
focused on harnessing the power of the human microbiome to treat challenging diseases, announced on November 30, 2017
an expansion of the investigator sponsored Phase 1 study of RBX7455 for the prevention of  recurrent Clostridium difficile (C. diff.) infection. The expansion follows the successful completion of the study’s two initial cohorts and is intended to explore reduced dosing regimens of RBX7455 in two new treatment arms. RBX7455 is a lyophilized, non-frozen oral capsule formulation of Rebiotix’s Microbiota Restoration Therapy™ (MRT), a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s  intestinal tract via a ready-to-use and easy-to-administer format.
“Expansion of the Phase 1 study is a key advancement in the development of RBX7455 as it provides an opportunity to explore the potential efficacy of reduced dosing regimens of our oral capsule product in the prevention of recurrent C. diff. infection,” stated Lee Jones, president and CEO of Rebiotix. “RBX7455 is a ground-breaking product in that its oral capsule design is the first in the microbiome industry not requiring storage in frozen conditions. As such, patients are able to administer RBX7455 at home as they would a typical oral capsule medication, which potentially makes RBX7455 ideally suited for diseases where chronic or repeat dosing is required.”
The Phase 1 study of RBX7455 is an investigator sponsored, prospective, single center, proof of concept dosing study of RBX7455 for the prevention of recurrent C. diff. infection. The first two arms enrolled 10 patients per arm (20 total). The expansion of the Phase 1 study adds two additional arms, which will enroll approximately 10 patients per arm (20 total) with reduced dosing regimens from the 2
first two arms. Rebiotix expects data from the first two cohorts of the Phase 1 study of RBX7455 to be released publicly by mid-2018.
In addition to the expanded Phase 1 study of RBX7455, Rebiotix’s clinical development pipeline is highlighted by the company’s ongoing Phase 3 clinical trial of RBX2660 for the prevention of recurrent C. diff. infection. RBX2660 is the first and only microbiome drug to be tested in three separate Phase 2 trials, with more than 300 subjects having been treated with the microbial therapy.
Recently, Rebiotix announced the presentation of research from the RBX2660 Phase 2 program demonstrating measurable evidence of the drug’s rehabilitative effect on the human microbiome and the potential advantages of its broad consortia design.
Ms. Jones continued, “We look forward to the continued progress of the RBX7455 Phase 1 study as well as our Phase 3 study of RBX2660, our lead microbiome drug candidate. Importantly, since both drugs were developed with our MRT platform, we can leverage knowledge from the extensive RBX2660 clinical program, as well as research into the drug’s rehabilitative impact on the gut microbiome, to inform and expedite the development of RBX7455.”
About Rebiotix Inc.
Rebiotix Inc. is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix possesses a deep and diverse clinical pipeline, with its lead drug candidate, RBX2660, in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff.) infection. RBX2660 has been granted Fast Track status, Orphan Drug and Breakthrough Therapy designation from the FDA for its potential to prevent recurrent C. diff. infection.
Rebiotix’s clinical pipeline also features RBX7455, a lyophilized nonfrozen,
oral capsule formulation, which is currently the subject of an investigator-sponsored Phase 1 trial for the prevention of recurrent C. diff. infection. In addition, Rebiotix is targeting several other disease states with drug products built on its pioneering Microbiota Restoration TherapyTM (MRT) platform.
MRT is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract via a ready – to-use and easy-to-administer format. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com

C Diff Foundation Welcomes Denise Graham, Assistant Public Relations

We are pleased to welcome Denise Graham
to the C Diff Foundation.

Denise Graham, Founder and President of DDG Associates, formerly the Executive Vice President to the Association for Professionals in Infection Control (APIC) and Epidemiology, led the nation’s public reporting initiative thereby enabling her to work closely with all agencies falling under the U.S. Department of Health and Human Services.  Her expertise in this arena continues by assisting clients with ongoing changes such as value-based purchasing and guidelines coming from the Centers for Disease Control and Prevention (CDC).

With greater than twenty years of experience in the healthcare industry, Denise has formed key working relationships with numerous leading experts.

Denise comes to the C Diff Foundation as Assistant Public Relations Coordinator  to introduce the organization with greater visibility and continued growth in educating and advocating for C.difficile Infection prevention, treatments, environmental safety and support worldwide.

To contact Denise:, please e-mail her at:    denise@cdifffoundation.org

Rapid Detection of a C. difficile Toxins Through Laboratory Testing Accelerates Diagnosis and Treatment

Abstract

BACKGROUND:

Clostridium difficile is an anaerobic, spore-forming and Gram-positive bacillus. It is the major cause of antibiotic-associated diarrhea prevailing in hospital settings. The morbidity and mortality of C. difficile infection (CDI) has increased significantly due to the emergence of hypervirulent strains.

Because of the poor clinical different between CDI and other causes of hospital-acquired diarrhea, laboratory test for C. difficile is an important intervention for diagnosis of CDI.

OBJECTIVE:

Laboratory tests for CDI can broadly detect either the organisms or its toxins. Currently, several laboratory tests are used for diagnosis of CDI, including

toxigenic culture,

glutamate dehydrogenase detection,

nucleic acid amplification testing, cell cytotoxicity assay,

and enzyme immunoassay towards toxin A and/or B.

This review focuses on the rapid testing of C. difficile toxins and currently available methods for diagnosis of CDI, giving an overview of the role that the toxins rapid detecting plays in clinical diagnosis of CDI.

 

https://www.ncbi.nlm.nih.gov/pubmed/27601055

 

Pediatric Review Focused On Diagnostics Available for Clostridium Difficile, Colitis, and Colonoscopy

Abstract

PURPOSE OF THE REVIEW: Review tests available for detection of Clostridium difficile (C. Diff) induced disease, including when such tests should be done in children and how they should be interpreted.

RECENT FINDINGS: Multiple tests are available for detecting disease due to C. diff. These include colonoscopy and stool analysis. Colonoscopy with biopsy is the most sensitive test for detecting the presence of colitis. The toxins produced by the C. diff. (toxin A, toxin B, and binary toxin) are the agents that cause injury and disease. Only toxin producing C. diff. Strains will cause disease. Binary toxin by itself is not thought to produce disease. Binary toxin causes disease in humans when present with toxin A and B producing bacteria, and has been implicated with fulminant life threatening disease. Stool analyses vary in sensitivity and specificity depending on the assay used. The presence of toxin producing strains of C diff. in the stool does not equate with disease. The presence of a toxin-producing bacteria or toxins (A or B) only equates with disease if diarrhea or a diseased colon (toxic megacolon, ileus, and sepsis) is present. Nucleic acid amplification testing (NAAT), when used in the stool from patients with diarrhea, appears to be the most efficient study to detect the gene that encodes for toxin A and B and thus to diagnose C. diff.-induced disease. Infants have a high carriage rate of C. diff. and are believed not to develop disease from it or its toxins. Infants should not be tested for C. difficile. The NAAT is most specific when done on patients with diarrhea with liquid stools. Testing for C. difficile should only be done on patients with diarrhea. One can assume that a patient who has no diarrhea and is not ill does not have C. diff.-induced disease. Treatment should be limited to patients with diarrhea who test positive for C. diff. toxin (A or B) or toxin-producing bacteria. Direct testing for binary toxin is not commercially available. Binary toxin is only thought to cause disease in humans when C. diff. toxin (A and B)-producing bacteria are present.

McConnie R, et al. Curr Gastroenterol Rep. 2017.

 

To review Abstract in its full entirety please click on the following link:

https://www.ncbi.nlm.nih.gov/m/pubmed/28707191/

Changing the Bed Linens In Sickness and In Health

According to Microbiologist, Phillip Tierno of New York University

our bed linens can “quickly blossom into a botanical park of bacteria and fungus.”

If left for too long, the microscopic life within the wrinkles and folds of our bed sheets can even make us sick,

> We can recall – years ago – the bed linens in any acute care facility (e.g., hospital) the bed linens were changed daily.   Food for thought <<

 

Humans naturally produce roughly 26 gallons of sweat in bed every year. When it’s hot and humid outside, this moisture becomes what scientists call an “ideal fungal culture medium.”

In a recent study that assessed the level of fungal contamination in bedding, researchers found that a test sample of feather and synthetic pillows that were 1 1/2 to 20 years old contained as many as 16 species of fungus each.

And it’s not just your own microbial life you’re sleeping with. In addition to the fungi and bacteria that come from your sweat, sputum, skin cells, and vaginal and anal excretions, you also share your bed with foreign microbes.

These include animal dander, pollen, soil, lint, dust mite debris and feces, and finishing agents from whatever your sheets are made from, to name a few.

Tierno says all that gunk becomes “significant” in as little as a week. And unclean bedding still exposes you to materials that can trigger the sniffing and sneezing, since the microbes are so close to your mouth and nose that you’re almost forced to breathe them in.

“Even if you don’t have allergies per se, you can have an allergic response,” Tierno said.

Another reason your sheets get dirty quickly has little to do with your behavior or sweat patterns — the issue is simply gravity.

“Just like Rome over time was buried with the debris that falls from gravity, gravity is what brings all that material into your mattress,” Tierno said.

One to two weeks of this buildup is enough to leave anyone with a scratchy throat — especially those with significant allergies or asthma. (One in six Americans has allergies.)

“If you touched dog poo in the street, you’d want to wash your hands,” Tierno said.

“Consider that analogous to your bedding. If you saw what was there — but of course you don’t see it — after a while you have to say to yourself, ‘Do I want to sleep in that?’

So what does Dr. Tierno suggest?

To stem the invisible tide, he said, sheets should be washed once a week — >> More Often when bed linens are visibly soiled and an infection is being treated <<


Proper ways to handle soiled linens:

There is now a common understanding that linens, once in use, are usually contaminated and could be harboring microorganisms such as MRSA and VRE.

Further, the Centers for Disease Control and Prevention (CDC) cautions that healthcare professionals should “handle contaminated textiles and fabrics with a minimum agitation to avoid contamination of air, surfaces, and persons.” Even one of the leading nursing textbooks, Fundamentals of Nursing, states, “Soiled linen is never shaken in the air because shaking can disseminate secretions and excretions and the micro organisms they contain.” This text also states, “…linens that have been soiled with excretions and secretions harbor microorganisms … can be transmitted to others.”

According to Fundamentals of Nursing, when handling linens in any acute care and healthcare facility:

1. You should always wash your hands after handling a patient’s bed linens.

2. You should hold soiled linen away from your uniform.

3. Soiled linen is never shaken in the air because shaking can disseminate the micro-organisms they contain.

4. Linen from one patient’s bed is never (even momentarily) placed on another patient’s bed.

5. Soiled linens should be placed directly into a portable linen hamper or tucked into a pillowcase and the end of the bed before it is gathered up for disposal in the linen hamper or linen chute.

 

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

http://www.businessinsider.com/how-often-to-wash-bed-sheets-2017-6