Category Archives: C diff Treatments

Two UK Researchers, Prof.Alistair Leanord and Dr. David Enoch, Present CDI Data At the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

Repeated infection with the bacterium Clostridium difficile (C. difficile, C.diff.), which causes abdominal pain, fever, diarrhea is linked to higher death rates, as well as having a significant impact on health services in terms of cost and hospital beds occupied.

In the first of two presentations at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) (tomorrow (Saturday), Professor Alistair Leanord, from Glasgow University, UK, will say that in Scotland the extra impact on the health service from C. difficile infections amounted to 10,600 bed days a year. “This is the equivalent to a 30-bed hospital ward being fully occupied all year,” he will say.

He will tell the congress that the (median) average cost of a patient with C. difficile infection was £7,500 (€8,600 approximately) compared to £2,800 (€3,200 approx) for patients with other medical conditions. In Scotland over a one year period, from October 2015 to October 2016, there were 1,150 cases of C. difficile infection in patients aged 15 and over. This cost the National Health Service (NHS) in Scotland a total of £8,650,000. Out of this amount, the additional costs of treating C. difficile infection, over and above the basic cost of a hospital bed and normal medical care, was £1,955,000. The calculations were carried out at Strathclyde University, which is part of the Scottish Healthcare Associated Infection Prevention Institute (SHAIPI) research consortium.

Until now, little has been known about the impact on health service resources from C. difficile infections, and on patients in terms of recurrence of infection, readmission to hospital, length of stay and death rates.

Prof. Leanord and his colleagues in Scotland identified 3,304 patients with C. difficile in Scottish hospitals between 2010 and 2013 and matched them with 9,516 patients who did not have the infection (the control group). Approximately two-thirds of the C. difficile patients acquired the infection in hospital.

They found that patients with C. difficile infection had more than double the risk of dying from any cause within two months of being admitted to hospital; nearly a third of all C. difficile cases (29%) died within two months compared to 14% of patients in the control group. Patients with C. difficile stayed in hospital a (median) average 9.7 days longer than the patients without the infection. Of the 1,712 C. difficile patients who were discharged from hospital within 30 days of the first episode of infection, 59% were readmitted within six months; of the 626 cases discharged more than 30 days after the first episode 53% were readmitted within six months. Few of these re-admissions were directly related to C. difficile infection.

“However, nearly a sixth of patients (14%) who were cured of the initial infection recurred within three months, and nearly one third of them (29%) had a second recurrence within a year,” says Prof. Leanord.

Older people were more vulnerable to a recurrence. Among the patients with C. difficile infection, 22% were aged 85 or over, and patients aged 75 and over had approximately double the risk of a recurrence of the infection compared to those aged under 65. Patients aged between 65-74 had 1.5 times the risk of recurrence compared to younger patients.

Prof. Leanord will conclude: “Having a clear understanding of the nature of C. difficile infections in Scotland will allow the Scottish government to target resources at the most appropriate patients to try to reduce the overall burden of the disease on the health service. Our findings are very likely to be applicable to the rest of the UK and other countries as well.”

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In a second presentation on Saturday, Dr David Enoch, a consultant microbiologist and infection control doctor at the National Infection Service, Public Health England, Cambridge (UK), will report the outcomes of 6,874 patients who had acquired C. difficile infection in hospital between 2002 and 2013 in England. Of these, 1,141 (16.6%) had recurrences of the infection.

“We found that 49% of hospital patients who suffer a recurrent episode of C. difficile infection die within a year, compared to 38% of those who suffer an initial infection only,” he will say. “In addition, 21% of patients with a recurrence suffered other complications as well, such as dehydration, malnourished and sometimes even perforation of the bowel, compared to 18% of patients who did not have a recurrence.”

Dr Enoch estimates that there are approximately 125,000 cases of C. difficile infection in Europe each year, and between 15-30% of these recur. “Cases in the UK have been coming down since 2008, which is most probably due to improvements in antibiotic prescribing and cleaning regimens in hospitals. This is encouraging but more still needs to be done.”

The average age of the patients was 77 and the average length of stay in hospital was 38 days.

“The main risk factor for developing C. difficile infection is prior antibiotic use. These patients are often already ill from some other underlying illness, which explains why they needed antibiotics in the first place. Older people are at greater risk of C. difficile infection as they are often sicker, have other illnesses or conditions, and so need more antibiotics,” he will say.

Dr Enoch continues: “Although much has been done, particularly in the UK, to try to prevent C. difficile infection, strict adherence to antibiotic guidelines by clinicians and thorough cleaning of the hospital environment are crucial in ensuring that patients don’t develop C. difficile infection in the first place. Treatment with a new drug called fidaxomicin has also been shown to reduce the risk of recurrence in patients who are unfortunate enough to develop an infection. However, we still have a lot to learn, particularly about how C. difficile infection occurs in the community, and how best to treat it.”

Treatments for recurrences of C. difficile infection  —–  include stopping the antibiotic that made the patient susceptible to the infection and starting a different antibiotic that is effective against C. difficile infection. These antibiotics include metronidazole, vancomycin and fidaxomicin. Supportive therapy, such as extra fluids, and surgery in serious or life-threatening cases may also be necessary. Faecal transplantation is emerging as a promising option; this is a process in which the good bacteria that the gut needs but which has been killed off by antibiotics is transplanted into the patient from a healthy donor.

(CDF:  Consider contacting an organization conducting Clinical Trials to Treat and Prevent.  Click on the following link for more information :  https://cdifffoundation.org/clinical-trials-2/

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Abstract no: #1672, presented by Prof. Alistair Leanord in the “Clostridium difficile infections: epidemiology and outcome” oral session, 16.30-18.30 hrs, Saturday 22 April, Hall A.

Abstract no: #883, presented by Dr Enoch in the “Clostridium difficile: guts and glory” e-poster mini-oral session, 15.30-16.30 hrs, Saturday 22 April, ePoster Arena 4.

 

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

https://www.eurekalert.org/pub_releases/2017-04/esoc-cdi041917.php

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).

ZINPLAVA (bezlotoxumab) Is Now Available For Prescription To Reduce Recurrence Of Clostridium difficile Infection (CDI)

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ZINPLAVA (bezlotoxumab) is now available for prescription.

Ordering information is available on the brand website:

http://www.zinplava.com/

What is Zinplava™ ?

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 a 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.

Full prescribing information can be read at

http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_pi.pdf

The Merck Access Program can help answer physician’s questions about:
Insurance coverage for patients
Prior Authorizations and Appeals
Coding and Billing
Potential financial assistance options for eligible patients

Full program details can be found at:

https://www.merckaccessprogram-zinplava.com/hcp/

Also, Information about co-pay assistance for eligible, privately insured patients
Information about available independent assistance foundation support.

 

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

 

Highlights Of the Latest Advances In the Battle Against the Deadly Pathogen – Dale Gerding, MD

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TO READ THIS ARTICLE IN ITS ENTIRETY AS PUBLISHED IN THE MD MAGAZINE — PLEASE CLICK ON THE FOLLOWING LINK TO BE REDIRECTED:

 

http://www.mdmag.com/medical-news/c-diff-foundation-highlights-latest-advances-in-the-battle-against-the-deadly-pathogen

In September, researchers, health care workers, and industry and patient advocates convened for the 4th Annual International Raising C. diff Awareness Conference and Health Expo in Atlanta.

Clifford McDonald, MD, Associate Director for Science in the Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention (CDC), chaired the conference. In his role at the CDC, McDonald’s at the forefront of efforts to prevent and treat the infection – one the CDC has declared among the most urgent drug-resistant threats that we currently face.

“It’s my firm belief that we are on the threshold of a new era in better diagnosis, treatment, and prevention approaches. At the CDC, we deal with statistics, but there are faces behind those numbers. At the heart of every infection is a patient who deserves our competence, our empathy, and our passion,” said McDonald.

One of those faces, Roy Poole, is a volunteer patient advocate for the  C Diff Foundation. After retiring from a career in the Air Force, Poole led a healthy, active lifestyle as an avid outdoors-man in Colorado before antibiotics prescribed for a routine dental procedure set the stage for CDI. In the medical community, his symptoms were met with disbelief and inappropriate treatment.

“Three weeks after leaving the hospital, I walked into my (previous) primary care physician, and asked for an order to have a stool sample taken to determine if Toxins A or B were present. His response was, ‘Are you still having problems with that?’ Clearly, there is a need for more education about C. diff among physicians,” said Poole.

CDI is a formidable opponent. However, with the newly focused attention on discovering ways to disable the bacteria and cohesive public health approaches aimed at prevention, presenters from government, academia and industry offered five key reasons we can win the battle against C. diff:

Antibiotic stewardship efforts are gaining a foothold.
Statistics present a chilling picture: 453,000 new cases and an estimated 30,000 deaths each year. It’s likely that those numbers grossly underestimate the true impact of CDI, since it’s what we know from death certificate reporting.

However, we are seeing that rates may have peaked after a long plateau. Mark Wilcox, MD, Head of Microbiology at Leeds Teaching Hospital, Professor of Medical Microbiology at University of Leeds, and the lead on Clostridium difficile for Public Health England in the United Kingdom, has demonstrated a 70% reduction in cases in England in just 7 years. This was after a concerted effort that Wilcox spearheaded surrounding antibiotic stewardship, specifically addressing a reduction in unnecessary prescribing of fluoroquinolones and cephalosporin antibiotics.

Commonly prescribed antibiotics disrupt the protective microbiota (the normal bacteria of the gut) and leave it vulnerable for C. diff colonization. “There was a concerted effort that went beyond lip service and truly embraced the principles of improved surveillance, more accurate diagnostics, enhanced infection prevention measures to use antibiotics more wisely and to limit transmission and careful treatment,” said Wilcox.

High rates of CDI are always associated with the use of certain antibiotics: clindamycin, cephalosporin, and fluoroquinolones. Research has shown that lower respiratory tract infections and urinary tract infections account for more than 50% of all in-patient antibiotics use. But are these really necessary?

“We know that antibiotics are overused and misused across every healthcare setting. At least 30% of antibiotic prescriptions are unnecessary – and this equates to 47 million unnecessary antibiotic prescriptions per year written in doctors’ offices, hospital outpatient departments, and emergency departments. We have a lot of work to do, and CDC is actively working to reduce unnecessary antibiotic use,” said Arjun Srinivasan, MD at the CDC. “Stopping unnecessary antibiotics is the single most effective thing we can do to curb C. diff infections in the United States. This is something that we can do today.”

Srinivasan acknowledged that telling patients that they can’t have a prescription for an antibiotic might result in some pushback. “Patient satisfaction scores are a very real concern. When someone is sick and takes a day off work, they’re not leaving without a prescription – especially when the last provider wrote one for their same symptoms,” he said. “But this is a new day, and it’s up to the physician to educate their patients and stay strong.”

Hospitalists have access to accurate, inexpensive and quick diagnostic tests that can lead to targeted, effective treatment. This can arm the treating physician and patient with information that can put patients on a path to recovery without feeling like they are being dismissed.

Emerging guidance reflects important advances in research and development.

Most recently published in 2010, the Society for Healthcare Epidemiology of America (SHEA) and Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for C. diff are currently under review. This is critical because of the number of physicians still treating with metronidazole first, despite the fact that the largest randomized controlled clinical trial has shown that vancomycin is more effective.

“Since 2010, the landscape has changed dramatically,” said Stuart B. Johnson, MD, Professor, Department of Medicine, Loyola University, and Researcher at the Hines VA Hospital in Chicago.

“The past few years have ushered in a new age of understanding how and where C. diff colonizes, and the damaging toxins A and B that it produces.”

Considering that 25-30% of patients experience a CDI recurrence, it’s evident that metronidazole unnecessarily contributes to the failed treatment outcomes for patients. Metronidazole is less expensive, but has more side effects than oral vancomycin and is less effective in treating CDI.

Johnson provided an overview of the dramatic advances this space has seen in just the past few years.

Limitations of current guidelines include:
•       No mention of fidaxomicin, a narrow-spectrum antibiotic, which in 2011 was the first medication approved in 25 years for the treatment of C. diff associated diarrhea
•       Limited evidence for recommendations to treat severe, complicated CDI
•       Limited evidence for recommendations on recurrent CDI
•       Little mention of Fecal Microbiota Transplant (FMT)

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5.  Patient advocacy and awareness efforts can alter the course of CDI.
CDI survivors shared their experiences along their emotional journey – fear, disbelief, isolation, and depression. They also expressed gratitude at the validation, information and support they received from the patient advocacy community. Perhaps the greatest gift they have received is the empowerment to question their physicians about the necessity of antibiotics they have been prescribed in terms of risk of CDI.

“The hospital where I was treated initially seemed eager to have me leave. They offered no additional help. The C diff Foundation has been my greatest source of help. In turn, I feel I help myself cope best, when I help others to cope with the disease,” said Poole.

TO READ THIS ARTICLE IN ITS ENTIRETY AS PUBLISHED IN THE MD MAGAZINE 

PLEASE CLICK ON THE FOLLOWING LINK TO BE REDIRECTED —- THANK YOU

http://www.mdmag.com/medical-news/c-diff-foundation-highlights-latest-advances-in-the-battle-against-the-deadly-pathogen

 

Dale Gerding, MD, FACP, FIDSA, is Professor of Medicine at Loyola University Chicago, Research Physician at the Edward Hines Jr. VA Hospital. Additionally, Gerding is an infectious disease specialist and hospital epidemiologist, past president of the Society for Healthcare Epidemiology of America and past chair of the antibiotic resistance committee of SHEA. He is a fellow of the Infectious Diseases Society of America and past chair of the National and Global Public Health Committee and the Antibiotic Resistance Subcommittee of IDSA. His research interests include the epidemiology and prevention of Clostridium difficile, antimicrobial resistance, and antimicrobial distribution and kinetics.

The paper, “Burden of Clostridium difficile Infection in the United States,” was published in the New England Journal of Medicine.

The study, “Changing epidemiology of Clostridium difficile infection following the intriduction of a national ribotyping-based surveillance scheme in England,” was published in the journal Clinical Infectious Diseases.

The study, “Prevalence of antimicrobial use in US acute care hospitals,” was published in JAMA.

The paper, “Vancomycin, metronidazole, or toleyamer for Clostridium difficile infection: results from two multinaionalm randomized, controlled trials,” was published in Clinical Infectious Diseases.

The study, “A Randomized Placebo-controlled Trial of Saccharomyces boulardii in Combination with Standard Antibiotics for Clostridium difficile disease,” was published in JAMA.

Clostridium difficile Treatment Strategies

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Authors: Teena Chopra, Ellie J.C. Goldstein, Sherwood L. Gorbach

  • First published: 20 December 2016 Full publication history
  • DOI: 10.1002/phar.1863View/save citation
  • Funding: This work was supported by Merck & Co., Inc., Kenilworth, New Jersey.
  • Disclosures: T.C. served as a speaker for Pfizer Inc., Merck & Co., Inc., Cubist Pharmaceuticals, Inc., and Actavis, plc. E.J.C.G. has participated in advisory boards sponsored by Merck & Co., Inc., Cubist Pharmaceuticals, Inc., Optimer Pharmaceuticals, Inc., Bayer AG, Bio-K Plus International, Inc., Summit Therapeutics, plc, Kindred Healthcare, Inc., Novartis Pharmaceuticals Corporation, Daiichi Sankyo Company, Ltd., and Rempex Pharmaceuticals, Inc. He has served as a speaker for Bayer AG, Merck & Co., Inc., Forest Laboratories, Inc., Optimer Pharmaceuticals, Inc., and Cubist Pharmaceuticals, Inc.; he has received research grants from Merck and Co., Inc., Schering-Plough Pharmaceuticals, LLC, Optimer Pharmaceuticals, Inc., Theravance Biopharma, Cubist Pharmaceuticals, Inc., Pfizer, Inc., Astellas Pharma US, Inc., Cerexa, Inc., Forest Laboratories, Inc., Impax Laboratories, Inc., Novartis Pharmaceuticals Corporation, Clinical Microbiology Institute, Genzyme Corporation, a Sanofi company, Nano Pacific Holdings, Inc., Romark Laboratories, LC, ViroXis Corp., Warner Chilcott, plc, AvidBiotics Corp., GLSynthesis, Inc., Immunome, Inc., Salix Pharmaceuticals, Inc., Summit Therapeutics, plc, GlaxoSmithKline plc, Rempex Pharmaceuticals, Inc., Symbiomix Therapeutics, Gynuity Health Projects, Durata Therapeutics, Inc., and Toltec Pharmaceuticals, LLC. S.L.G. has served as a consultant for Seres Therapeutics, Inc., Medimmune, LLC, and Cempra Pharmaceuticals. He was also a consultant for Cubist Pharmaceuticals, now Merck & Co, Inc., at the time that the manuscript was written.

Abstract

In recent years, Clostridium difficile infection (CDI) has become a global public health threat associated with increased morbidity, mortality, and economic burden, all of which are exacerbated with disease recurrence. Current guidelines informing treatment decisions are largely based on definitions of disease severity at diagnosis, with subjective components not well delineated across treatment algorithms and clinical trials. Furthermore, there is little evidence linking severity at onset to outcome. However, reducing the risk of recurrence may offer both a better outcome for the individual and decreased downstream economic impact.

The authors present data supporting the opinion that patients deemed at low risk for recurrence should receive vancomycin (or metronidazole when cost is an issue), while those at higher risk of recurrence would benefit from fidaxomicin treatment.

Although further prospective studies are needed, choosing treatment with the goal of preventing recurrent CDI may offer a better guide than disease severity.

To access entire article – click on the following link:

http://onlinelibrary.wiley.com/doi/10.1002/phar.1863/full

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.

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

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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

CDiffAwarenessRibbon2015

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 – – – – – –

DoubleTreeLogo

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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

 

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#Cdiff2016