Tag Archives: C. difficile prevention

Hospital Collaborative Measures Show Positive Results In Driving Down C difficile Infection (CDI) Rates In New York

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In the news

Each hospital had been trying to combat C. difficile on its own, but they were often outwitted by the hardy spore, which is fueled by overuse of antibiotics, spread by hands  and able to survive on bed rails, call buttons and doorknobs for as long as five months if not longer and cleaned off.

Plus, it was traveling: Patients in one hospital or nursing home were often discharged and then admitted to another. Dealing with the mess was costing the hospitals an estimated $4 million to $5 million a year.

So they did something rare for competing health-care systems. Four hospitals joined forces to beat back the debilitating bug, forming a C. difficile prevention collaborative. Six nursing homes that share patients with the hospitals and had a huge C. difficile problem of their own then formed a separate alliance.

It paid off: In the 12 months ended in September 2015, rates of C. difficile infections fell 36% from 2011 levels across the hospitals, which initially were in three but are now in two health-care systems: the University of Rochester Medical Center and Rochester Regional Health System.

“It’s not very simple—you have to have a multidisciplinary approach to prevent this infection,” says Ghinwa Dumyati, who leads both the hospital and nursing-home collaboratives as an infectious-disease physician with the Center for Community Health at the University of Rochester Medical Center. “We needed to work together.”

A good cleaning

Hospitals compete intensely for patients, doctors and insurance dollars, but when it comes to safety, they are increasingly collaborating to solve common problems, according to Arjun Srinivasan, an expert at the Centers for Disease Control and Prevention in the prevention of health-care-associated infections. The CDC says working together allows hospitals to more effectively fight infections caused by drug-resistant bacteria and C. difficile because the bugs are intractable and the difficulties each facility faces are similar. Plus, Dr. Srinivasan says, “hospitals share those patients.”

New federal requirements to improve health-care quality, such as public reporting of health-care-associated infections and penalties for readmissions, also are prodding hospitals to collaborate more on safety issues, Dr. Srinivasan and hospital executives say.

C. difficile is the most common pathogen causing health-care-associated infections in U.S. hospitals, according to the CDC. It led to approximately 453,000 infections and 29,000 deaths in the U.S. in 2011, according to a study last year in the New England Journal of Medicine.

Infections occur when someone ingests C. difficile and takes antibiotics that wipe out the good bacteria in their gut. That leaves the C. difficile to flourish in the colon, producing diarrhea that can last for weeks or months. The elderly are particularly at risk of infection because their immune systems may be weak, and they are frequent users of hospitals and nursing homes.

Rochester’s C. difficile-prevention collaborative began in 2011, funded by the health-care

systems involved and a large regional insurer, Excellus BlueCross BlueShield. It grew out of an earlier initiative that Dr. Dumyati had led that sharply reduced bloodstream infections from central lines, or catheters, inserted in the body. This time, the collaborative—Dr. Dumyati, along with doctors, infection preventionists and others from the hospitals—

chose to target C. difficile. “We knew we had a lot of cases,” she says.

First, the collaborative focused on cleaning procedures. The hospitals taught staff to scrub long and hard with bleach wipes to get rid of super-resilient C. difficile in hospital rooms. “Just like if you’re washing a plate, you have to apply pressure to get food off,” says Jeanna Hibbert, who cleans rooms at Strong Memorial Hospital, one of the four participating hospitals.

They also introduced inspections of cleaned rooms, using a tool that checks for even small amounts of contamination. “That was new and extraordinarily helpful,” says Robert Panzer, chief quality officer and associate vice president at Strong Memorial.

Each hospital made changes in its own way, and borrowed ideas from the others. Strong Memorial dedicated a crew to clean the rooms of discharged C. difficile patients after determining that it takes an hour and half—twice as long as normal—to properly clean them, adopting a practice from its sister, Highland Hospital.

After the collaborative laid out a policy for treating less severe forms of pneumonia, Strong Memorial pharmacists changed an electronic order form for antibiotics to prevent physicians treating those infections from prescribing a class of drugs linked to C. difficile infection without special approval, says Dr. Dumyati.

Across town at Rochester General Hospital, staff promoted the new pneumonia policy in a newsletter for doctors. Use of the desired antibiotic, doxycycline, for pneumonia more than tripled in a year; use of the one it replaced fell 48%, the hospital says.

The team at Rochester General also created a poster with new guidelines for diagnosing and treating urinary-tract infections after the collaborative determined that five out of six of its hospital patients treated for them don’t actually have them. Dr. Dumyati adopted it for use in the nursing homes she had started to work with, with a grant from the state.

The new policies have helped Rochester General strengthen an antibiotic stewardship program it adopted a few years ago, in which a team of experts reviews antibiotic prescriptions, says Maryrose Laguio-Vila, the program’s director. “We gain insight into whether what we’re doing is along the right track or can be tweaked in a certain way.”

The collaborative has helped all of the hospitals improve their practices and patient care, says Nayef El-Daher, chief of infectious disease at Unity Hospital. “When we started the project, every one of us had [our] own ideas and protocols,” he says.

The next front

Dr. Dumyati feeds data on C. difficile infection rates and other measures every quarter to each of the hospitals, so that they can see how they’re doing. “The data really drive where we go next,” she says.

Next, she hopes to take the new policies to doctors’ and dentists’ offices. About 35% of all C. difficile infections aren’t linked to stays in hospitals or long-term-care facilities, according to the NEJM study.

“It’s fairly clear that you have to work with the nursing homes and you have to work across the community to make progress,” says Mark Shelly, chief of infectious disease at Highland Hospital. “Otherwise we’ll be pointing across the fence for a long time.”

 

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

 

http://www.wsj.com/articles/rochester-hospitals-unite-to-defeat-a-common-foe-c-difficile-1455592271

Using Antibiotics Wisely, How Everyone Can Help In the Fight Against Antibiotic Resistance Worldwide

Did you have the opportunity to listen  to the live broadcast on “C. diff. Spores and More Global Broadcasting Network”  on Tuesday, February 9th, 2016 with guests Dr. Lori Hicks and Dr. Arjun Srinivasan from  the Centers of Disease Control and Prevention (CDC) ?

Dr. Hicks and Dr. Srinivasan discussed how to use antibiotics wisely and how everyone can help in the fight against antibiotic-resistance.

This important  information  is now available to you on demand by clicking directly on the logo below

 

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For additional information on Inpatient Antibiotic Stewardship please click on the following link:

http://www.cdc.gov/getsmart/healthcare/inpatient-stewardship.html

 

To access the CDC Get Smart Program, please click on the following link to be redirected:

http://www.cdc.gov/getsmart/index.html

 

 

C. diff. Spores and More” programming is brought to you by VoiceAmerica  and sponsored by Clorox Healthcare

For more information please visit the C. diff. Spores and More program page:

https://cdifffoundation.org/c-diff-radio/

C diff Spores and More Global Broadcasting Network and Guests Dr. Srinivasan and Dr. Hicks of the CDC Discuss Antibiotic Resistance

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C. diff. Spores and More , Global Broadcasting Network – innovative and educational interactive healthcare talk radio show discuss antibiotic resistance and what everyone can do to join in the fight against it with guests Dr. Arjun Srinivasan and
Dr. Lauri Hicks on Tuesday, February 9th at 10 AM Pacific Time on VoiceAmerica Health and Wellness Channel

Bringing guests together, such as Dr. Arjun Srinivasan, MD and Dr. Lauri Hicks, DO from the Center of Disease Control and Prevention (CDC), one of the leading government healthcare organizations in the U.S., and internationally recognized experts on antibiotic resistance has built a loyal listenership and continue to inform and educate listeners’ worldwide.

C.diff. Spores and More” is broadcast live every Tuesday at 10 AM Pacific Time on the VoiceAmerica Health and Wellness channel, officially sponsored by Clorox Healthcare. Archived C. diff. Spores and More shows can be found Here.

“I am so proud to be the Senior Executive Producer of the “C. diff. Spores and More,” program as it continues to raise awareness, on a global level, of the overuse of antibiotics. Having guests; Dr. Arjun Srinivasan, MD and Dr. Lauri Hicks, DO truly affect change in both the leadership and education guiding the public and raising awareness in many areas of health care,” stated Robert Ciolino, Senior Executive Producer VoiceAmerica.

About The C diff Foundation Executive Director
Nancy C Caralla, hosts “C. diff. Spores and More” Global Broadcasting Network with a team focus on educating, and advocating for C. diff. infection prevention, treatments, and environmental safety – and more — worldwide.

For information please visit www.cdifffoundation.org

Listen in on Tuesday, February 9th at 10:00 Pacific Time–

https://cdifffoundation.org/c-diff-radio/

Antibiotic Resistance Is Everybody’s Business – Don’t Wait Another Day To “Get Smart: Know When Antibiotics Work”

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Dr. Judy Stone, MD made good points about how we have a long way to go to be where the CDC would like us to be in both knowledge and practice focused on Antibiotics.   ” Last year, the Wellcome Trust brought us grim news about antibiotic resistance, with dire projections that 10 million people might die each year due to resistance, and equally severe economic consequences.”

Through the  “Get Smart” campaign and programs offered everyone can gain valuable knowledge about Antibiotics.  The Centers For Disease Control and Prevention (CDC) provides the  Get Smart: Know When Antibiotics Work educational  programs for the general public, for farming, and healthcare.

Take a moment and review the CDC’s “Get Smart” information provided on their website and diligently advocate for the safety and the proper use of antibiotics worldwide.

(An excerpt from Dr. Stone’s article)

At last week’s C. diff Foundation conference, Dr. Hudson Garrett suggested that physicians employ a slightly different tactic. Rather than give in to demands for an unnecessary and harmful antibiotic prescription, he suggested that the patients receive a written prescription for specific symptomatic relief products, to provide this sense of validation and to boost satisfaction. It would be nice to see if this can be verified through studies.

Patients seem to have a love-hate relationship with antibiotics, both wanting them, and yet feeling they are a “harsh” and “necessary evil.” This in turn leads many to stop taking them early, not wanting their body to “grow immune”—and not understanding that it is the bacteria that become resistant to antibiotics. This was a widespread belief that appears difficult to overcome.

http://www.forbes.com/sites/judystone/2015/11/18/cdc-says-its-time-to-get-smart-about-antibiotics-weve-got-a-long-way-to-go/2/

Additional information presenting the “Get Smart” Know When Antibiotics Work

 

Antibiotic Resistance Is Everybody’s Business

 

Synthetic Biologics Announced Positive Topline Results From the First Phase 2a Study Of SYN-004 For C. difficile Infection Prevention

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Synthetic Biologics Announces Positive Topline Results from First Phase 2a Clinical Trial of SYN-004, the Company’s Candidate for the Prevention of C. difficile Infection

Synthetic Biologics, Inc. a clinical stage company focused on developing therapeutics to protect the gut microbiome while targeting pathogen specific diseases, announced positive topline results from the first Phase 2a study of SYN-004, the Company’s candidate designed to protect the gut microbiome from the unintended effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention C. difficile infection (CDI) and antibiotic-associated diarrhea (AAD). Topline results from the ten ileostomized participants who completed the Phase 2a open-label study demonstrated that SYN-004 successfully degraded residual IV ceftriaxone in the chyme (digestive fluid in the small intestine) without affecting the intended level of ceftriaxone in the bloodstream.

Evaluation of the chyme from the ileostomized participants indicates that both dosage strengths of SYN-004 (75 mg and 150 mg) degrade residual IV ceftriaxone present in the chyme, supporting the mechanism of action of SYN-004. In addition, both dosage strengths of SYN-004 appear to be well tolerated by the participants in the study. Overall, the topline data support the hypothesis that SYN-004 has the capacity to degrade residual IV ceftriaxone in the GI tract, thereby preserving the balance of the gut microbiome for the prevention of CDI, AAD and emergence of antibiotic-resistant organisms, without affecting the antibiotic level in the bloodstream intended for treatment of a primary infection.

“The completion of the first Phase 2a clinical trial for SYN-004 is an important achievement for Synthetic Biologics. These positive topline results demonstrate the potential for SYN-004 to protect the gut microbiome from the damaging effects of certain IV beta-lactam antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea,” stated Jeffrey Riley, President and Chief Executive Officer of Synthetic Biologics. “The second Phase 2a clinical trial for SYN-004 is currently ongoing to evaluate the GI antibiotic-degrading effects and the safety of SYN-004 in the presence of the proton pump inhibitor (PPI), esomeprazole, in participants with functioning ileostomies. We anticipate reporting topline results from the second Phase 2a of SYN-004 during the first half of 2016.”

Mr. Riley concluded, “We are pleased to report additional progress from our SYN-004 program. We have begun dosing patients in the SYN-004 Phase 2b proof-of-concept clinical trial that is intended to evaluate the effectiveness of SYN-004 to prevent C. difficile infection and C. difficile associated diarrhea, as well as antibiotic-associated diarrhea in up to 370 patients hospitalized for a lower respiratory tract infection and receiving IV ceftriaxone.”

 

First SYN-004 Phase 2a Clinical Trial Design

The Phase 2a randomized, multi-center, open-label study evaluated the ability of two different dose strengths of SYN-004 to degrade residual IV ceftriaxone in the GI tract of 10 healthy participants with functioning ileostomies, without affecting the concentrations of IV ceftriaxone in the bloodstream. The study consisted of two treatment phases for all participants: 1) the administration of IV ceftriaxone alone, and 2) the administration of IV ceftriaxone with one of two dosage strengths of oral SYN-004. Chyme samples were collected from the participants to measure the capability of SYN-004 to degrade the residual antibiotic in the GI tract. Participants were enrolled at two trial sites located in Canada.

 

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

http://money.cnn.com/news/newsfeeds/articles/prnewswire/CL69745.htm

 

— SYN-004 Degraded IV Ceftriaxone in Gastrointestinal Tract without Affecting
Antibiotic Levels in the Bloodstream —
— First Patients Dosed in Phase 2b Proof-of-Concept Clinical Trial for SYN-004 —
— SYN to Host Microbiome Clinical Program Seminar in NYC on Thursday, December 10, 2015

This release includes forward-looking statements on Synthetic Biologics’ current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the potential for SYN-004 to protect the gut microbiome from the damaging effects of certain IV beta-lactam antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea, the timing of the reporting of topline results from the second Phase 2a of SYN-004, the potential market for SYN-004, and the intended therapeutics results of SYN-004 and SYN-010. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics’ forward-looking statements include, among others, a failure to receive the necessary regulatory approvals for commercialization of Synthetic Biologics’ therapeutics, a failure of Synthetic Biologics’ clinical trials, and those conducted by investigators, to be commenced or completed on time or to achieve desired results, a failure of Synthetic Biologics’ clinical trials to receive anticipated funding, a failure of Synthetic Biologics’ products for the prevention and treatment of diseases to be successfully developed or commercialized, Synthetic Biologics’ inability to maintain its licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2014 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

i  Leffler DA et al. N Engl J Med 2015; 372:1539-1548.

ii Leffler DA et al. N Engl J Med 2015; 372:1539-1548.

 

 

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

 

Allegheny General Hospital (AGH) Enrolls Patients In a Clinical Study Of Investigational Vaccine for Prevention Of Leading Healthcare-Associated Infection; Clostridium difficile

Allegheny General Hospital (AGH), part of Allegheny Health Network, announced that it will enroll patients in a clinical study to evaluate the safety and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile infection (CDI).

Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. While most types of healthcare-associated infections (HAIs) are declining, C. diff is emerging as a leading cause of life-threatening, HAIs worldwide. The infection poses the greatest danger for older adults in hospitals or long-term care facilities who take broad-spectrum antibiotics.

Allegheny General joins more than 200 sites across 17 countries around the world in the Cdiffense clinical trial, a Phase III randomized, observer-blind, placebo-controlled study. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization of more than 72 hours for a surgical procedure. People in this age group who have had at least two hospital stays, each lasting more than 24 hours, and have received systemic antibiotics in the past year are also eligible.

“With the emergence of difficult-to-manage strains of C. diff, CDI has become more frequent, more severe and more difficult to treat in recent years, raising concerns about how to control it and prevent transmission,” explained Zaw Min, MD, an infectious disease specialist who is serving as principal investigator of the trial at AGH. “Vaccination could be an efficacious, cost-effective and important public health measure to protect individuals from C. diff.”

For more information, contact:

 

For more information about the Cdiffense Phase III clinical trial, please contact AGH’s study coordinator at 412.359.3095 or visit www.Cdiffense.org

Merck’s Phase 3 Studies of Bezlotoxumab, its Investigational Antitoxin to Prevent C. difficile Recurrence Met Primary Endpoint

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Merck  known as MSD outside the United States and Canada, announced that the two pivotal Phase 3 clinical studies for bezlotoxumab, its investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence, met their primary efficacy endpoint: the reduction in C. difficile recurrence through week 12 compared to placebo, when used in conjunction with standard of care antibiotics for
the treatment of C. difficile.

Based on these results, the company plans to submit new drug applications seeking regulatory approval of bezlotoxumab in the U.S., EU and Canada in 2015. Currently, there are no therapies approved for the prevention of recurrent disease caused by C. difficile.

“These results were also demonstrated in patient subgroups known to be at
high risk for C. difficile recurrence.”

Results from the studies were presented for the first time at the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and International Congress of Chemotherapy and Infection (ICC) joint meeting in San Diego, Sept. 17-21.

“Results of these studies showed that a single, one-time infusion of the antitoxin bezlotoxumab given with standard of care C. difficile antibiotic treatment significantly reduced the recurrence of C. difficile infection compared to standard of care alone, and demonstrated this benefit over a 12-week period,” said Dr. Mark Wilcox, Leeds Teaching Hospitals and University of Leeds, U.K., and a lead investigator for the studies. “These results were also demonstrated in patient subgroups known to be at high risk for C. difficile recurrence.”

Bezlotoxumab is not an antibiotic. It is a selective, fully-human, monoclonal antibody designed to
neutralize C. difficile toxin B, a toxin that can damage the gut wall and cause inflammation, leading to the symptoms of C. difficile enteritis, which include abdominal pain and watery diarrhea.

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 licensed to Merck in 2009 for development as a potential
therapeutic for C. difficile infection.

“Recurrence is a major challenge with C. difficile infection, and novel approaches are
needed to help prevent the cycle of C. difficile recurrence,” said Dr. Dale Gerding, professor of medicine, Loyola University Chicago Stritch School of Medicine, Maywood, Ill., and a lead investigator for the studies.

About the pivotal Phase 3 studies

Two global, Phase 3, double-blind studies were conducted to evaluate bezlotoxumab, either alone or in combination with actoxumab (a fully human monoclonal antibody against C. difficile toxin A), compared to placebo for the prevention of recurrent C. difficile infection in patients on standard of care antibiotics for a primary or recurrent C. difficile infection. The MODIFY I study (MONOCOLONAL ANTIBODIES FOR C. DIFFICILE THERAPY) enrolled 1452 patients (median age 65 years) in 19 countries and the MODIFY II study enrolled 1203 patients (median age 67 years) in 17 countries. The studies were conducted in both hospital and outpatient settings, and the primary endpoint for each study was evaluated through 12 weeks following study drug administration.

In the MODIFY I study, patients receiving standard of care antibiotics for C. difficile were randomized to receive a single, one-time infusion of either bezlotoxumab (10 mg/kg) (n=403), actoxumab (10 mg/kg) (n=242), the combination of bezlotoxumab and actoxumab (10 mg/kg each) (n=403) or placebo (n=404). The actoxumab arm was stopped for efficacy and safety reasons after an interim analysis. In the MODIFY II study, patients receiving standard of care antibiotics for C. difficile were randomized to receive a single, one-time infusion of either bezlotoxumab (10 mg/kg) (n=407), bezlotoxumab and actoxumab (10 mg/kg each) (n=397) or placebo (n=399).

In both MODIFY I and MODIFY II, the rate of C. difficile infection recurrence through week 12, the primary efficacy endpoint, was significantly lower in the bezlotoxumab arms (17.4%, p=0.0003) and (15.7%; p=0.0003), and the combination bezlotoxumab and actoxumab arms (15.9%, p<0.0001) and (14.9%, p<0.0001), compared to the placebo arms (27.6%) and (25.7%), respectively. In MODIFY I and MODIFY II, 1396 and 1163 patients were evaluated in the full analysis sets, respectively.

In both studies, the rate of C. difficile infection recurrence was lower in the bezlotoxumab arms compared to the placebo arms in patient subgroups known to be at high
risk for C. difficile recurrence, including patients with any prior
episode(s) of C. difficile infection within the previous six months, patients infected with the BI/NAP1/027 strain, patients with severe C. difficile infection (Zar score ≥ 2), patients 65 years of age or older, and patients with compromised immunity. These subpopulation analyses were pre-specified in the protocol for each study.

In the studies, the adverse reaction rates were comparable across the bezlotoxumab and placebo arms. In MODIFY I, the most common adverse reactions through four weeks after infusion (nausea, diarrhea and pyrexia) occurred at similar rates in the bezlotoxumab group (7.4%, 6.7% and 5.6%) and the placebo group (6.5%, 5.0% and 2.8%). In MODIFY II, the most common adverse reactions through four weeks after infusion (nausea, diarrhea and urinary tract infection) occurred at similar rates in the bezlotoxumab group (5.8%, 5.3% and 4.5%) and the placebo group (3.4%, 6.6% and 4.2%). Additionally, rates of serious adverse reactions and deaths assessed through 12 weeks after infusion were comparable across these treatment arms.

Treatment with the combination of bezlotoxumab and actoxumab did not provide added efficacy over bezlotoxumab alone. Furthermore, actoxumab alone provided no benefit in the prevention of C. difficile recurrence compared with placebo. Based on these results, bezlotoxumab alone was selected for the marketing authorization application.

About Merck

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of 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 healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

 

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

http://www.businesswire.com/news/home/20150920005053/en/Pivotal-Phase-3-Studies-Bezlotoxumab-Merck%E2%80%99s-Investigational#.VgFWTpftVQs

 

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