Monthly Archives: October 2014

Clostridium difficile Research and Development Community; October 2014

Here’s the latest from the Clostridium difficile research community:
The role of hosts gut microbiome plays a critical role in the development of Clostridium difficile infection. Different antibiotic usage leads to the loss of specific bacterial taxa that can lead to different levels of susceptibility to C. difficile. In this study, Buffie et al. report that Clostridium scindens, a bile acid 7α-dehydroxylating intestinal bacterium, is associated with resistance to CDI which is dependent on secondary bile salts. The major take-home message is that microbiome research can help in identifying potential risks following specific antibiotic treatment and also treatment options such as probiotics.
http://www.nature.com/nature/journal/vaop/ncurrent/full/nature13828.html

In the following study, the authors evaluate the safety and rate of resolution of diarrhea following oral FMT with frozen capsules given to patient volunteers with recurrent CDI. Twenty patients received 15 capsules on 2 consecutive days and these patients were followed for 6 months. No SAEs were reported. Diarrhea was resolved in 14 patients following 1 FMT. 4 out of 6 nonresponders resolved after a second FMT, with an overall 90% resolution rate. Larger studies are needed to confirm the current findings.
http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2014.13875

 

The use of synthetic polymers as mimics of host-defense antibacterial peptides have been studied by the McBride lab. In vitro analysis of Nylon 3 copolymers against C.difficile shows that peptide LL37 is capable of blocking vegetative cell-growth and inhibiting spore outgrowth and is effective against ribotype 027 and 012 strains, in contrast to vancomycin and nisin. These easy to produce synthetic polymers could be used as a treatment for a CDI.
http://pubs.acs.org/doi/abs/10.1021/ja506798e

 

The following study looks at the role of IL22 and CD160 in the mucosal inflammatory immune response to a CDI. The authors report that in C. difficile-infected mice treated with anti-IL22, anti-CD160 or a combination of the two, STAT3 phosphorylation was significantly reduced compared to infected mice not receieving these antibodies. These treated mice also had reduced influx in neutrophils. These data show that IL22 and CD160 are responsible for a proinflammatory host mucosal response against during CDI in mice.
http://onlinelibrary.wiley.com/doi/10.1111/imm.12414/pdf

 
And lastly, Norway rats (Rattus norvegicus) also known as New York City rats have been found to be widely infected with many common human pathogens such as atypical enteropathogenic Escherichia coli, Clostridium difficile, and Salmonella enterica, as well as infectious agents that have been associated with undifferentiated febrile illnesses, including Bartonella spp., Streptobacillus moniliformis, Leptospira interrogans, and Seoul hantavirus and viruses such as sapoviruses, cardioviruses, kobuviruses, parechoviruses, rotaviruses, and hepaciviruses. Pest control is doubly important in urban settings where these rodents are carriers of such zoonotic diseases and live in close proximity to humans.
http://www.ncbi.nlm.nih.gov/pubmed/25316698

 

Chandrabali Ghose-Paul,MS,PhD, Chairperson of Research and Development

North Carolina Get Smart Partner - Antimicrobial Stewardship Campaign

North Carolina Get Smart

Antimicrobial Stewardship Campaign

Antibiotics Awareness Week November 17 – 23, 2014

The goal of the NC Get Smart Campaign is to reach all 100 North Carolina counties’ public and provider audiences with the CDC Get Smart Antimicrobial awareness message. Antimicrobial drugs are lifesavers and a vital resource to be preserved. The overuse of antibiotics has led to increased resistance of known infections. The NC Get Smart Campaign for NC begins on November 17, 2014 and completes on June 30, 2015.

Get Smart About Antibiotics Week logo web button

This webpage contains resources that you can utilize to promote awareness of antimicrobial drug overuse.

 

 

GETSMARTScreen-Shot-2014-10-22-at-4.47.09-PM

 

NC Get Smart Partners

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“Raising C. difficile Awareness Week” is coming: Are you prepared?

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Rosie D. Lyles, MD, MHA

Rosie D. Lyles, MD, MHA

Clinical Affairs Head at The Clorox Company

Member of the C Diff Foundation Research and Development Committee

“Raising C. difficile Awareness Week” is coming: Are you prepared?

As many people in the healthcare and infectious disease industry are aware, Clostridium difficile (C. difficile) infections remain a significant problem in the United States. The U.S. Centers for Disease Control and Prevention (CDC) reports that about 250,000 C. difficile infections occur per year that require hospital treatment or affect those already hospitalized. On top of that, each year an estimated 14,000 people die from C. difficile infection.

The severity of this problem is one reason why I am proud to join the C Diff Foundation’s Research and Development Committee and Research Community. The C Diff Foundation works to provide support for those affected by C. difficile, raises awareness about the problem and works to help healthcare facilities and patients implement preventative measures.

Please join me and the C Diff Foundation in celebrating “Raising C. difficile Awareness Week” starting Nov. 1 to spread the word about C. difficile prevention, treatment and environmental safety.

C. difficile infections are preventable, so healthcare facilities need to focus on the following strategies (adapted from the Centers for Disease Control and Prevention) to help protect their patients, staff and visitors from infection:

C. difficile Prevention Tips:

  1. Antibiotic Stewardship – Prescribe and use antibiotics carefully. Unnecessary use can raise infection risks.
  2. Test – If a patient has diarrhea while on antibiotics or after taking them, order a C. difficile test right away to confirm whether he/she is infected.
  3. Isolation Precautions – Immediately isolate patients with confirmed cases of C. difficile or who are exhibiting symptoms (e.g., diarrhea).
  4. Personal Protective Equipment – Always perform hand hygiene with soap and water before and after contact with infected individuals. Wear gloves and gowns when treating C. difficile patients and ensure that staff uses them properly to avoid cross-contamination risks.
  5. Environmental Decontamination – Clean the facility, especially rooms of patients with C. difficile, with bleach or another EPA-registered spore-killing disinfectant. Make sure you follow manufacturers’ instructions for dilution and contact time, the length of time the surface needs to remain wet for the product to work. Also consider supplementing standard terminal cleaning with an ultraviolet (UV-C) system.
  6. Alert – If a patient with C. difficile transfers, notify the new facility of their condition so they can take the proper precautionary measures.

To download a free infographic poster on preventing C. difficile facility wide, visit: http://www.cloroxprofessional.com/industry/health/knowledge-expertise/cdiffinfographic/

I hope to see you Nov. 4 at the “Raising C. difficile Awareness” conference at the University of Illinois at Chicago! Visit the C Diff Foundation website for more information.

Banatrol® Plus with Bimuno Prebiotic For Diarrhea

Advertised Product Available: Banatrol Plus formulated to provide nutrients for the dietary management of diarrhea without medication.

To treat diarrhea associated with a C. difficile infections, G. I. virus, and Flu * * Always discuss and seek medical advice from a Healthcare Professional/Physician prior to adding any supplements or over-the-counter medications * Medical Food *

http://www.medtrition.com/banatrol-diarrhea-relief/

Banatrol® Plus with Bimuno Prebiotic for Diarrhea

Banatrol Plus is specifically formulated to provide nutrients for the dietary management of diarrhea without medication.

A dual acting combination of natural banana flakes and prebiotic to control the severity and length of time patients suffer from diarrhea while enhancing the good bacteria in the gut. Banatrol Plus does not affect gut motility and will not cause constipation so it can be used as soon as C difficile is suspected.

Conditions: For the dietary management of diarrhea caused by infectious disease and flu, antibiotic induced diarrhea, C difficile tube feeding associated diarrhea and chemotherapy induced diarrhea.

Gluten Free
Can be used orally or through a feeding tube.

Medical Food.
Banatrol Plus is a medical food. Use under supervision of a qualified medical specialist.

 

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http://www.homedelivered.com/Banatrol-Plus

Synthetic Biologics, Inc. Is Issued a Notice of Allowance for a Composition of Matter Patent Application covering SYN-004, Leading Product in its C. difficile Program

* In the news *

Synthetic Biologics, Inc., a biotechnology company developing novel pathogen-specific therapies for serious infections and diseases, announced that as of October 22, 2014 the U.S. Patent and Trademark Office has issued a Notice of Allowance for a composition of matter patent application that covers the lead product in its C. difficile program, SYN-004. This is Synthetic Biologics’ first allowed patent application directly pertaining to SYN-004 in the U.S. and adds to the Company’s extensive C. difficile patent estate.

Synthetic Biologics, Inc. Logo

SYN-004 is Synthetic Biologics’ novel oral enzyme drug candidate designed as the first and only prophylactic treatment intended to prevent the development of C. difficile infections, by binding with and neutralizing certain intravenous (IV) beta-lactam antibiotics in the gut.

SYN-004 is intended to block the effects of antibiotics within the gastrointestinal (GI) tract, maintaining the natural balance of bacterial flora (the gut microbiome), potentially preventing the 1.1 million C. difficile infections in the U.S. each year. The U.S. patent to be issued has claims to compositions of matter and pharmaceutical compositions of beta-lactamases, including SYN-004, and carries a patent term to at least 2031. In addition to the newly allowed patent, the Company has numerous related granted and pending U.S. and international patent applications that are central to the Synthetic Biologics’ intellectual property estate.

“This new patent will strengthen the protection of Synthetic Biologics’ SYN-004 and reiterates our position as a key player in the prevention of microbiome-based diseases,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “We continue to bolster the Company’s patent estate while making progress towards our goals to initiate Phase Ia and Ib C. difficile clinical trials this quarter.”

 

Resource: Synthetic Biologics news release.

C Diff Foundation Promoting C. difficile Prevention and Awareness to Witness a Decrease in C. difficile Infections Worldwide

November is C. difficile Infection Awareness Month! Join us in the fight by participating in a variety of events that let you support the cause while doing the things you love to do. Here’s a listing of many ways the C Diff Foundation is spreading awareness with ways to prevent acquiring this infection while raising funds.

Take the Antibiotic “Resistance Fighter” Pledge

How to be a resistance fighter? Limit the use of Antibiotics! Understand that antibiotics are only effective against bacteria and not viruses: colds, flu and most coughs are caused by viruses and will get better on their own. Treat your flu and cold symptoms and let your immune system fight the virus. Antibiotics will not help you get better quickly, and may give you side effects such as diarrhea and thrush. They can also lead to acquired C. diff. infections. They won’t stop your virus spreading to other people only YOU can do that with good hand hygiene. Don’t ask for antibiotics , instead ask your doctor about the best way to treat your symptoms. If you are prescribed antibiotics ask your doctor about the risks and benefits and always take them exactly as prescribed. Never take someone else’s antibiotics, always speak with your Primary Care Physician (PCP) or healthcare professional when symptoms linger or worsen.

Let us all take the “Resistance Fighter” Pledge and feel free to share the pledge with everyone you know:
I will not expect antibiotics for colds and flu as they have no effect on viruses.
I will take antibiotics as directed IF I am prescribed them, and not ask for them.
I will practice good hygiene, making hand washing #1, and help stop giving germs a free ride.

Now we can ALL spread knowledge, not infections and encourage others to join the fight against antibiotic resistance.

“Get Smart: Know When Antibiotics Work” CDC Campaign :

Get Smart About Antibiotics Week has been an annual effort to coordinate the work of CDC’s Get Smart: Know When Antibiotics Work campaign, state-based appropriate antibiotic use campaigns, non-profit partners, and for-profit partners during a one week observance of antibiotic resistance and the importance of appropriate antibiotic use. The campaign organized its first annual Get Smart About Antibiotics Week in 2008. CDC’s Get Smart campaign, housed in the National Center for Immunization and Respiratory Diseases, collaborated with state-based appropriate antibiotic use campaigns and non-profit and for-profit partners. The success of the pilot year was measured by 1) dissemination of educational materials and messages, 2) partner satisfaction, and 3) media interest. A robust evaluation of the pilot week determined that each of these goals was met and exceeded. This was followed by other successful Get Smart About Antibiotics Week observances.

During November 17-23, 2014, the annual Get Smart About Antibiotics Week will be observed. As in past years, the effort will coordinate work of CDC’s Get Smart: Know When Antibiotics Work campaign, state-based appropriate antibiotic use campaigns, non-profit partners, and for-profit partners during a one week observance of antibiotic resistance and the importance of appropriate antibiotic use. As with the past observances, messages and resources for improving antibiotic use in healthcare settings from CDC’s Get Smart for Healthcare campaign will be included. Get Smart for Healthcare is a program housed in CDC’s National Center for Emerging and Zoonotic Infectious Diseases.

  • Ask your physician questions such as, “Do I really need an antibiotic?”
  • Bacteria only, not viruses (common cold, flu), can be killed by antibiotics.
  • Complete the entire course of prescribed antibiotics, even if you feel better midway through.

Antibiotic resistance occurs when bacterial changes reduce or eliminate an antibiotic’s ability to kill the bacteria.

The Association of Professionals in Infection Control and Epidemiology (APIC) recommends the following:

  • Take antibiotics only and exactly as instructed by your healthcare provider.
  • Only take antibiotics prescribed for you.
  • Do not save or share antibiotics prescribed to you.
  • Do not pressure your healthcare provider to prescribe you antibiotics.

 

SHOPPING:

Shop Amazon to Give to the C Diff Foundation

It’s a pleasure to share the new way to give to the C Diff Foundation. Amazon will share a portion of the proceeds from your purchases with the C Diff Foundation. While you are shopping on-line you are also donating, and we are grateful. Here is how it works:

* Shop Amazon through AmazonSmile and select C Diff Foundation as your charity.

Click on the link below to access their site.

https://smile.amazon.com/

Sign into your Amazon Account with ID and Password. Scroll down past the default chosen Charity and at the following option

Or pick your own charitable organization:________

Type in C Diff Foundation and press Enter

C Diff Foundation Inc (About)
Specifically Named Diseases New Prt Rchy, FL
Click the SELECT button

It is as easy as that!

Education:

2nd Annual “Raising C. difficile infection and Hospital-Associated Infections (HAI’s) Awareness” Conference on November 4th, 2014 at 8:00 am. The event will be hosted at the University of Illinois at Chicago Student Center West,
828 S. Wolcott Avenue, M. M. Thompson Room - C, Chicago, IL 60612

Twitter chats and daily tweets in honor of Raising C. difficile infection Awareness Week From November 1st through November 7th.

worldaroundCDF Volunteers continue sharing information within their communities, and organizing Fundraisers during the month of November to raise C. difficile infection awareness, prevention, treatments, and environmental safety worldwide. Each Volunteer is a special leaf, on each branch of this growing Foundation tree. Our sincere gratitude to every one of our Volunteers!!

Follow the C Diff Foundation on Facebook, Twitter @CDiffFoundation, Pinetrest, and LinkedIn and join the fight.

Thank you for your support that helps our mission continue moving forward. Educating and advocating for C. difficile infection prevention, treatments, and environmental safety worldwide.

Be sure to check our C Diff Foundation page often as new events are added weekly.

Rebiotix, Inc. announces results of Phase 2 Punch(TM) CD Study for Treatment of Recurrent C. difficile infections

In The News*

Rebiotix Inc. announced today that results of the Phase 2 PUNCH™ CD Study found that the overall efficacy of RBX2660 in the treatment of recurrent Clostridium difficile infection was 87.1%. The study also found that administration of RBX2660 was well-tolerated and demonstrated satisfactory safety in the 60-day interim analysis.

The results of a 60-day interim analysis of the PUNCH CD study, the first prospective multi-center study of a next generation, standardized, commercially prepared microbiota restoration therapy for recurrent CDI were presented at IDWeek 2014.

Clostridium difficile infection, characterized by severe diarrhea, is a leading healthcare acquired infection and is linked to 14,000 deaths in the U.S. annually. The U.S. Centers for Disease Control recently termed CDI an urgent public health threat. Recurrent CDI is especially challenging to treat, and there are no indicated drugs for the condition.

The primary objective of the PUNCH CD study was product-related adverse events (AEs). A secondary objective was CDI resolution. A total of 40 patients at 11 centers in the U.S. were enrolled in the study. All of the patients had multi-recurrent CDI and had failed standard therapy. The PUNCH CD patient population was primarily elderly and female with multiple co-morbidities, thus reflecting the real-world population of patients with recurrent CDI who present with unmet medical needs.

A total of 34 patients received at least one dose of RBX 2660 administered via enema. A second dose was permitted if CDI recurred

“Years of experience indicate microbiota therapy is highly efficacious for treatment of recurrent CDI. However, adequate data have been lacking on safety,” said Erik R. Dubberke, MD, MSPH, a PUNCH CD investigator and Director, Section of Transplant Infectious Diseases at Washington University School of Medicine, St. Louis, MO. “The phase 2 study indicates RBX2660 efficacy is consistent with past studies, and it is safe and easy to administer.”

The study represents a significant step forward in Rebiotix’s efforts to develop a durable cure for recurrent CDI that is debilitating to patients. RBX2660 will undergo further study in a Phase 2B randomized controlled trial scheduled to begin later this fall.

About Rebiotix Inc.
 Rebiotix Inc. is a results-oriented biotechnology company revolutionizing the treatment of challenging gastrointestinal diseases by harnessing the power of the human microbiome. The Roseville, Minn. based company is pioneering Microbiota Restoration Therapy to restore healthy gut flora through the transplantation of live microorganisms. For more information, visit http://www.rebiotix.com

Rebiotix is the only company that has a microbiota therapy with FDA orphan-drug designation for treatment of recurrent C. diff. infection. Orphan drugs are those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and/or disorders that affect fewer than 200,000 people in the US. The FDA has also designated RBX2660 as a Fast Track product for the treatment of recurrent C. diff. infection. This designation underscores the urgent need for a new therapy to treat patients who have this debilitating and potentially life-threatening disease and means that FDA will act to expedite the development and review of the application for the product, as appropriate.

 

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

https://ca.finance.yahoo.com/news/study-shows-rebiotix-microbiota-based-135200811.html

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