Tag Archives: Gastroenteroligist

Severe Cases of C.diff. Infection (CDI)Study Suggests the Most Routinely Prescribed Antibiotic Is Not the Best Treatment

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Over the past two decades there has been a sharp rise in the number and severity of infections caused by the bacteria Clostridium difficile  (C. diff ) now the most common healthcare-acquired infection in the United States.

 

As published – to view the article in its entirety please click on the link below to be redirected:

https://www.eurekalert.org/pub_releases/2017-02/uou-rpa020117.php

But a new study suggests that the most routinely prescribed antibiotic is not the best treatment for severe cases. Scientists at the VA Salt Lake City Health Care System and University of Utah report that patients with a severe C. diff infection (CDI) were less likely to die when treated with the antibiotic vancomycin compared to the standard treatment of metronidazole.

The findings will be published online on Feb. 6, 2017 on the Journal of the American Medical Association (JAMA) Internal Medicine website.

C. diff does not cause illness outright. The bacterium produces two chemicals that are toxic to the human body. These toxins work in concert to irritate the cells of the Large intestinal lining producing the symptoms associated with the illness. Symptoms of CDI include watery diarrhea, fever, loss of appetite, nausea, and abdominal pain and tenderness. Severe cases are associated with inflammation of the colon.

Current guidelines primarily recommend two antibiotics metronidazole or vancomycin to treat CDI. While vancomycin was the original treatment, the medical community has favored metronidazole for the past few decades, because it is less expensive and will limit vancomycin resistance in other hospital-acquired infections. The guidelines are based on small clinical trials carried out about 30 years ago.

“For many years the two antibiotics were considered to be equivalent in their ability to cure C. diff and prevent recurrent disease,” says Stevens. “Our work and several other studies show that this isn’t always the case.” In the current issue of JAMA Internal Medicine, the research team looked at the effectiveness of the two drugs by comparing the risk of mortality after treatment with these two antibiotics.

The investigators conducted the largest study to date by examining the data from more than 10,000 patients treated for CDI through the US Department of Veterans Affairs healthcare system from 2005 to 2012. A severe case of CDI was defined as a patient with an elevated white blood cell count or serum creatinine within four days of the CDI diagnosis. A mild to moderate case of CDI was defined as a patient with normal white blood cell counts and creatinine levels. About 35 percent of cases in this study were considered severe.

Patients with a severe case of CDI had lower mortality rates when treated with vancomycin compared to metronidazole (15.3 percent versus 19.8 percent). The scientists calculated that only 25 patients with severe CDI would need to be treated with vancomycin to prevent one death. “That is a powerful, positive outcome for our patient’s well-being,” explains Stevens. She cautions that the researchers still do not understand how the choice of antibiotic affects mortality rates.

“Although antibiotics are one of the greatest miracles of modern medicine, there are still tremendous gaps in our knowledge about when and how to use them to give our patients the best health outcomes,” explains Michael Rubin, M.D., Ph.D., an associate professor in internal medicine and an investigator at the VA Salt Lake City Health Care System.

“This research shows that if providers choose vancomycin over metronidazole to treat patients with severe CDI, it should result in a lower risk of death for those critically ill patients,” said Rubin. This study showed that less than 15 percent of CDI patients, including severe cases, received vancomycin.

The study results did not show a difference in the rate of the illness returning following either antibiotic treatment whether the initial illness was mild to moderate or severe. Nor did it show a difference for the rate of death following either antibiotic treatment for mild to moderate CDI cases.

Stevens cautions that the study was observational in nature and does not prove cause and effect of the drug. In addition, the study focused on patients that were primarily men; however, past studies show that the C. diff treatment outcomes for men and women were similar.

According to Stevens, future work should balance the targeted application of vancomycin treatment, especially for severe CDI cases, with economic considerations and the consequences of antibiotic resistance. “The optimal way to move forward is to do decision analysis that allows us to weigh the pros and cons of the various treatment strategies,” she says.

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The research was funded by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Health Services Research and Development.

In addition to Stevens and Rubin, co-authors include Richard Nelson, Karim Khader, Makoto Jones, Lindsay Croft and Matthew Samore (University of Utah and the VA Salt Lake City Health Care System), Elyse Schwab-Daugherty and Kevin A. Brown (Public Health Ontario and University of Toronto), Tom Greene (University of Utah), Melinda Neuhauser (VA Pharmacy Benefits Management Services) and Peter Glassman and Matthew Bidwell Goetz (VA Greater Los Angeles Healthcare System).

MD Peer Exchange Focus On Clostridium difficile Infections

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Courtesy of MDMag .com

MD Magazine

 

 

Listen and View Panelists:  Peter L. Salgo, MD; Erik Dubberke, MD; Lawrence J. Brandt, MD; Dale N. Gerding, MD; and Daniel E. Freedberg, MD, MS,

Topic of discussion:  Understanding Why Clostridium difficile Infections (CDI) Occur In the Community

The second video the panelists discuss:

The Pathophysiology of Clostridium difficile Infection (CDI)  and Its Impact On the Gastrointestinal System.

See more at: http://www.mdmag.com/peer-exchange/clostridium-difficile-infections/understanding-why-clostridium-difficile-infections-occur-in-the-community#sthash.r4Z6jNwk.dpuf

 

 

U.S. Food and Drug Administration (FDA) Has Approved Merck’s (MSD) ZINPLAVA ™ (bezlotoxumab) Injection 25mg/ml To Reduce Recurrence Of Clostridium difficile Infection In Patients 18 Years Of Age Or Older

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Merck  known as MSD outside the United States and Canada, on October 22, 2016 announced that the U.S. Food and Drug Administration (FDA) has approved ZINPLAVA™ (bezlotoxumab) Injection 25 mg/mL.

Merck anticipates making ZINPLAVA available in first quarter 2017.

ZINPLAVA is indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence.

ZINPLAVA is not indicated for the treatment of CDI.

ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.

Please see Prescribing Information for ZINPLAVA (bezlotoxumab) at http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_pi.pdf 

 

Patient Information for ZINPLAVA at http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_ppi.pdf

CDI is caused by bacteria that produce toxins, including toxin B. Symptoms of CDI include mild-to-severe diarrhea, abdominal pain and fever. The incidence of recurrent CDI is higher in certain patient populations, including people 65 years of age or older and those with compromised immune systems.

“For generations, Merck has been steadfast in its commitment to fighting infectious diseases – and that commitment continues today. ZINPLAVA is a human monoclonal antibody that binds to C. difficile toxin B and neutralizes its effects,” said Dr. Nicholas Kartsonis, vice president of clinical development, infectious diseases, Merck Research Laboratories.

Selected safety information about ZINPLAVA

Heart failure was reported more commonly in the two Phase 3 clinical trials in ZINPLAVA-treated patients compared to placebo-treated patients. These adverse reactions occurred primarily in patients with underlying congestive heart failure (CHF). In patients with a history of CHF, 12.7% (15/118) of ZINPLAVA-treated patients and 4.8% (5/104) of placebo-treated patients had the serious adverse reaction of heart failure during the 12-week study period. Additionally, in patients with a history of CHF, there were more deaths in ZINPLAVA-treated patients [19.5% (23/118)] than in placebo-treated patients [12.5% (13/104)] during the 12-week study period. The causes of death varied, and included cardiac failure, infections, and respiratory failure. In patients with a history of CHF, ZINPLAVA (bezlotoxumab) should be reserved for use when the benefit outweighs the risk.

The most common adverse reactions occurring within 4 weeks of infusion with a frequency greater than placebo and reported in ≥4% of patients treated with ZINPLAVA and Standard of Care (SoC) antibacterial drug therapy vs placebo and SoC antibacterial drug therapy included nausea (7% vs 5%), pyrexia (5% vs 3%) and headache (4% vs 3%).

Serious adverse reactions occurring within 12 weeks following infusion were reported in 29% of ZINPLAVA-treated patients and 33% of placebo-treated patients. Heart failure was reported as a serious adverse reaction in 2.3% of ZINPLAVA-treated patients and 1.0% of placebo-treated patients.

In ZINPLAVA-treated patients, 10% experienced one or more infusion specific adverse reactions compared to 8% of placebo-treated patients, on the day of or the day after, the infusion. Infusion specific adverse reactions reported in ≥0.5% of patients receiving ZINPLAVA and at a frequency greater than placebo were nausea (3%), fatigue (1%), pyrexia (1%), dizziness (1%), headache (2%), dyspnea (1%) and hypertension (1%). Of these patients, 78% experienced mild adverse reactions, and 20% of patients experienced moderate adverse reactions. These reactions resolved within 24 hours following onset.

As with all therapeutic proteins, there is a potential for immunogenicity following administration of ZINPLAVA. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to bezlotoxumab in two Phase 3 studies with the incidence of antibodies in other studies or to other products may be misleading. Following treatment with ZINPLAVA in these two studies, none of the 710 evaluable patients tested positive for treatment-emergent anti-bezlotoxumab antibodies.

About bezlotoxumab

Bezlotoxumab was developed by researchers at the University of Massachusetts Medical School’s MassBiologics Laboratory in conjunction with Medarex (now part of Bristol-Myers Squibb), and was licensed to Merck in 2009.

Please see Prescribing Information for ZINPLAVA (bezlotoxumab) at http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_pi.pdf 

 

About Merck

For 125 years, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships.

For more information, visit www.merck.com

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

http://www.pharmiweb.com/PressReleases/pressrel.asp?ROW_ID=187373#.WAsjR8li9kk

 

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

ProNourish ™ Nutritional Drink Information For Healthcare Professionals — For Patients With Food Intolerance And Digestive Discomfort

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*Please note – The
C Diff Foundation does not endorse any product and/or clinical study in progress. All website postings are strictly for informational purposes only. If you have questions, please contact the companies directly. Thank you.

 

FOR HEALTHCARE PROFESSIONALS **

………………………

For Patients with Food Intolerance
ProNourish™ Nutritional Drink is a unique option for patients who suffer with digestive discomfort and are following an exclusion diet.

It was specifically formulated with the guidance of healthcare professionals to be compliant with a Low FODMAP Diet and is Low FODMAP Certified by Monash University. Monash University Low Fodmap Certified™
Benefits in every bottle:
Low in FODMAPs*
3 g of Fiber
15 g of High Quality Protein
25 Essential Vitamins and Minerals
Suitable for Lactose Intolerance**

NO Gluten
NO High Fructose Corn Syrup
NO Sugar Alcohols or Artificial Colors
NO Inulin
NO Fructooligosaccharides
ProNourish™ Nutritional Drink helps make following a Low FODMAP Diet easier by providing a balanced mini-meal or snack without the ingredients that might trigger symptoms of digestive discomfort. Its just one more way Nestlé Health Science strives to help nourish patients quality of life through the power of nutrition.
HEALTHCARE PROVIDERS ONLY: Order Free Samples!
For Your Patients
To get your FREE samples, use promo code PRON-13851-1016.

Find out more about ProNourish™ Drink at ProNourish.com

or visit LowFODMAPcentral.com

For information and handouts for your patients.

Stop by the ProNourish™ Drink booth during these upcoming events!

2016 Food & Nutrition Conference & Expo™ (FNCE®): October 16–18
(booth #2951)
2016 ACG American College of Gastroenterology Meeting: October 16–18
(booth #1114)

*Formulated to be low in specific carbs (called FODMAPs) that can be difficult for some people to digest.

**Not for individuals with Galactosemia.

Monash University Low FODMAP Certified™ trademarks used under license by Nestlé.

A strict Low FODMAP Diet should only be commenced under the supervision of a healthcare professional.

U.Va.’s Division of Infectious Diseases and International Health Could Lead To a New Treatment For C. diff. Infection (CDI)

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Every year, about half a million patients are infected by Clostridium difficile, an otherwise harmless bacterium that can multiply out of control when the use of antibiotics upsets the balance of microorganisms in the gut. In 2011, about 15,000 deaths were directly attributable to the infection, according to a recent study by the federal Centers for Disease Control and Prevention (CDC).

Current probiotic treatments, which promote the growth of helpful bacteria, have been ineffective against the infection, also known as C. diff.

But work being done at U.Va.’s Division of Infectious Diseases and International Health could lead to a new treatment by the end of the calendar year, according to Dr. Bill Petri, chief of the division. That’s an unusually optimistic estimate in medical research, where scientific breakthroughs predate new treatments by several years.

“Some of these advanced probiotics are actually being tested today in the clinic for their role,” Petri said. “We’re actually participating in advanced clinical trials at U.Va.”

Immunologist Erica L. Buonomo was the driving force behind the new discovery, Petri said, which has to do with the role of white blood cells in protecting against C. diff.

Buonomo found that a particular type of white blood cells, called eosinophils, act as a barrier against the infection, which breaks down the lining of the gut. These eosinophils are recruited by a protein called IL-25. A serious C. diff infection kills eosinophils, allowing the bacteria to enter the gut.

The researchers found that gut bacteria stimulate the production of IL-25, so the right probiotic could help with the production of protective eosinophils.

“We identified a pathway in the immune response that reduces the severity of an infection,” Buonomo said. “When we activate this pathway, we find mice are a lot less sick.”

The discovery would be especially helpful for elderly patients, who are most at risk. It also could have larger implications in the world of microbiology.

Eosinophils are best known for their role in allergic reactions and asthma attacks, when a high number of eosinophils cause inflammation.

The function of these cells was not entirely clear before Buonomo’s discovery. She believes this knowledge could help doctors fight other types of gastrointestinal disorders, such as irritable bowel syndrome.

U.Va. is now working on a probiotic with a Boston-based firm called Seres Therapeutics 

The finished product will be tested in Charlottesville, Petri said.

To read the article in its entirety please click on the link below:

C. difficile Infection (CDI) Prevention, Treatment, Environmental Safety, Research, Clinical Trials Being Discussed with World Topic Experts On September 20th In Atlanta, Georgia USA

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September 20th

It is with great pride and certainty in the power of the healthcare community to present the 4th Annual International Raising. C. diff. Awareness Conference and Health Expo

being hosted at the

DoubleTree by Hilton — Atlanta Airport 
3400 Norman Berry Drive
Atlanta,Georgia 30344 USA  (Hotel Phone: 1-404-763-1600)

Doors open at 7:15 a.m — Sign In and Continental Breakfast

Conference begins at: 7:30 a.m. – 5:00 p.m.

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Raising C. difficile awareness is essential to build upon and advance existing knowledge and necessary for overcoming the challenges our healthcare communities are faced with today.

“None of us can do this alone — All of us can do this together”

Nearly half a million Americans suffered from Clostridium difficile (C. diff.) infections in a single year according to a study released February 25, 2015 by the Centers for Disease Control and Prevention (CDC).   C. diff. is a leading cause of infectious disease death worldwide; 29,000 died within 30 days of the initial diagnosis in the USA.   Previous studies indicate that C. diff. has become the most common microbial cause of healthcare-associated infections found in U.S. hospitals driving up costs to $4.8 billion each year in excess health care costs in acute care facilities alone.

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Cdiff2015-1Clinical professionals gather for one day to present up-to-date data to expand on the existing knowledge and raise awareness of the urgency focused on a Clostridium difficile infection (CDI) —

    • Prevention
    • Treatments
    • Research
    • Environmental Safety
    • Clinical trials and studies

WITH

  • Microbiome research, studies
  • Infection Prevention
  • Fecal Microbiota Restoration and Transplants for Adults & Pediatrics
  • A Panel Of C. diff. Infection Survivors
  • Antibiotic Stewardship
  • Healthcare EXPO
    ……………………and much more.

You won’t want to miss out on this opportunity to learn from
International topic experts delivering data directed at evidence-based
prevention, treatments, and environmental safety in the C. diff.
and healthcare community.

Gain insights on September 20th that will not be available anywhere else with an opportunity to receive up-to-date data on major topics in this program being presented in one day.

5 Leading reasons to attend this dynamic conference:

  • Learn from leading healthcare professionals, clinicians, researchers, and industry.
  • Networking opportunities with new and reconnect with those in the healthcare community with similar interests.
  • Gain breakthrough results through research in progress and gaining positive results. Programs focused on Antibiotic-resistance such as the  Antibiotic Stewardship making a difference. Front line developments in progress focused on C. diff. infection prevention, treatments, environmental safety.
  • Implement and share the knowledge well after the conference ends.  Every attendee receives a booklet with guest speakers information, media to review audio programs, and Health Expo Sponsor information focused on the important agenda topics.
  • Embrace the opportunity, with all of the topic experts presenting, and hold the conference in the highest priority from the participation in this conference to an audience of medical students, and fellow healthcare professionals, who will benefit the most from the data and gain tools to overcome the barriers facing healthcare each day.

“The information and up-to-date studies shared at the 2015 conference added to an existing knowledge base that helps us to continue delivering quality care in the medical community.”   Linda Davis, RN,BSN

 ……………………………………………………………………………………………………………..

REGISTRATION FEES:

$75.00  —  Conference Registration

$30.00  —  Student Conference Registration (Student ID To Be Presented At the Door)

TO REGISTER Click on the “Raising C. diff. Awareness” Ribbon below

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Room accommodations are available —  Complete and Confirm 

by August 19th to reserve your hotel reservations.   

To create a reservation please click on the DoubleTree By Hilton Logo below – – – – – –

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 A suggested travel coordinator, for your convenience

LibertyTraveldownloadMichael Beckman — Team Leader,  Liberty Travel, 467 Washington Street, Boston, MA  02111
617-936-2435
Michael.Beckman@flightcenter.com

 For Additional Information visit the C Diff Foundation Website:

https://cdifffoundation.org/

https://cdifffoundation.org/

And Click on the 2016 September Conference Tab

 

Follow us on Twitter
@cdiffFoundation
#Cdiff2016

European Patent Office Has Granted European Patent Which Provides Composition Of Matter Coverage For Synthetic Biologics’ ribaxamase

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Synthetic Biologics; a clinical stage company focused on developing therapeutics to protect the gut microbiome announced on July 12, 2016  that the European Patent Office has granted European Patent No. 2576776 which provides composition of matter coverage for ribaxamase, the Company’s Phase 2 drug candidate designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of Clostridium difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms.

This is Synthetic Biologics’ first patent directly pertaining to ribaxamase in Europe and adds to the Company’s established and extensive patent estate.

In addition, the U.S. Patent and Trademark Office (USPTO) has granted
US Patent No. 9,376,673, and issued a Notice of Allowance for another application (US 15/160,669), with composition of matter claims for various beta-lactamase candidates related to ribaxamase. These new patent assets further strengthen the Company’s coverage of its novel proprietary candidate, ribaxamase, which is also covered by a previously granted composition of matter patent in the U.S.

“The successful granting of this composition of matter patent in Europe, alongside our continued patent successes in the U.S., further strengthens Synthetic Biologics’ role as a leader in the development of microbiome-focused programs intended to address largely unmet medical needs,” said Jeffrey Riley, President and Chief Executive Officer. “As we continue to enjoy momentum in the clinic, our progress is further complimented by our well established and reinforced patent estate for ribaxamase.”

Ribaxamase is designed to degrade certain intravenous (IV) beta-lactam antibiotics excreted into the gastrointestinal (GI) tract to maintain the natural balance of the
gut microbiome.

C. difficile is associated with approximately 453,000 CDIs and > 29,000 C. difficile-related deaths in the United States each year[i].

Upon issuance, these newly allowed applications reinforce Synthetic Biologics’ extensive C. difficile-related patent estate, which includes approximately 40 U.S. and foreign patents and approximately 30 U.S. and foreign patent pending applications, and patents and patent applications with terms that extend from at least 2031 to 2036.

 

To read this article in its entirety click on the link below:

http://ir.syntheticbiologics.com/press-releases/detail/216