Tag Archives: Healthcare

Lactose Free Vanilla Pudding Recipe

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Pudding is one of those easy and quick comforting desserts that can be prepared anytime  and enjoyed as an after school snack or dessert. This dairy-free (Lactose Free) pudding recipe is always a hit and it’s easy.

 

Ingredients:  (makes 4 Servings)  (t. = teaspoon, T=Tablespoon)

 

  • 2/3 cups white granulated sugar
  • ¼ t. salt
  • ¼ cup cornstarch
  • 2 ½ cups unsweetened plain almond milk or other non-dairy milk alternatives   (Soy, Cashew, Rice, Coconut, etc..).
  • 4 large egg yolks
  • 1 t. vanilla extract
 Directions:
  1. In a small saucepan, whisk together the sugar and salt.
  2. In a small dish, combine the cornstarch with 2 T. of the almond milk, mixing until dissolved. Add the cornstarch mixture, remaining milk of your choice and egg yolks to the saucepan, whisking until combined.
  3. Cook the pudding over medium heat, stirring constantly, until mixture thickens and bubbles just begin to form on the surface.
  4. Whisking constantly, turn down the heat to low and cook for about 1 minute more.
  5. Pour the pudding through a fine sieve into a heatproof dish and stir in the vanilla extract.
  6. Place plastic wrap directly on the surface of the pudding and chill at least 2 hours before serving.

 

 

Synthetic Biologics SYN-004 (ribaxamase) Achieves Primary Endpoint in Phase 2b Trial for C. difficile Infection

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Synthetic Biologics’ SYN-004 (ribaxamase) Achieves Primary Endpoint
in Phase 2b Trial for C. difficile Infection (CDI)

 

Synthetic Biologics, Inc. a late-stage clinical company developing therapeutics
that preserve the microbiome to protect and restore the health of patients, today
announced positive topline data from its Phase 2b clinical trial for SYN-004 (ribaxamase),
the Company’s first-in-class oral enzyme designed to protect the gut microbiome
from disruption caused by certain intravenous (IV) beta-lactam antibiotics.

The study, a randomized, double-blind, placebo controlled trial of 412 patients, met its primary endpoint of significantly reducing C. difficile Infection (CDI). Preliminary analysis of the data indicated seven confirmed cases of CDI in the placebo group compared to two cases in the ribaxamase treatment group. Patients receiving ribaxamase achieved a 71.4% relative risk reduction (p-value=0.045) in CDI rates compared to patients receiving placebo. Adverse events reported during this trial were comparable between treatment and placebo arms.

Synthetic Biologics is also in the process of analyzing data from several exploratory endpoints that were designed to evaluate ribaxamase’s ability to protect the gut microbiome from colonization by opportunistic bacteria such as C. difficile and other antibiotic-resistant pathogens. Preliminary analysis of the data demonstrated a significant reduction in new colonization by vancomycin-resistant enterococci (VRE) for patients receiving ribaxamase compared to placebo (p-value=0.0002). With agreement from the FDA, the study included a secondary endpoint to assess ribaxamase’s capacity to decrease the incidence of antibiotic-associated diarrhea from all causes. Preliminary analysis of the data suggested a trend towards such a reduction (p-value=0.13), which was due, for the most part, to the reduction of CDI.

These data are consistent with ribaxamase’s mechanism of action designed to protect and preserve the natural balance of the gut microbiome from the unintended effects of IV antibiotic use. The Company expects to share additional results from these exploratory endpoints as they become available later this year, including results focused on ribaxamase’s ability to prevent the emergence of antimicrobial resistance in the gut microbiome.

“These trial results provide a compelling demonstration of the potential of ribaxamase to help address the serious health impacts associated with CDI and infections from other opportunistic bacteria resulting from dysbiosis of the gut microbiome,” said Joseph Sliman, MD, SVP, Clinical and Regulatory Affairs. “More than 453,0001 patients are diagnosed with CDI annually in the U.S., resulting in approximately 29,0001 deaths as well as significant and sometimes prolonged illness. Ribaxamase has the potential to shorten hospital stays, diminish morbidity and mortality and reduce the emergence of antibiotic-resistant organisms in the gut microbiome by protecting patients from primary C. difficile infection resulting from IV antibiotic use.”

In addition to causing significant suffering and mortality, CDI adds an estimated economic burden of nearly $1.5 billion1 to the healthcare system each year, which could potentially be reduced with an effective therapeutic.

“The reduction in the relative risk of CDI represents a significant milestone in the clinical development of ribaxamase and we believe provides further validation for our approach to advancing cutting edge microbiome science,” said Jeffrey Riley, President and Chief Executive Officer. “These findings also help further our goals to bring the first ever microbiome-focused therapeutic to patients and to help illuminate the potential of this drug class to address serious diseases and public health concerns. We expect to share additional data from exploratory endpoints in the coming months and look forward to continuing ongoing and productive discussions with both the FDA and CDC on the protocol for Phase 3 pivotal trials for ribaxamase.”

Synthetic Biologics is also continuing to prepare for the initiation of pivotal Phase 2b/3 clinical trials for SYN-010, the Company’s proprietary, modified-release formulation of lovastatin lactone designed to treat the underlying cause of irritable bowel syndrome with constipation (IBS-C).

Presentation Planned for Biotech Showcase 2017 Conference

Date: Monday, January 9, 2017
Time: 9:30 a.m. (PT) / 12:30 p.m. (ET)
Location: Hilton San Francisco Union Square, San Francisco, CA

A live webcast of Synthetic Biologics’ presentation may be accessed by logging onto the internet at https://event.webcasts.com/viewer/event.jsp?ei=1130367. After the presentation, a replay will be archived and accessible for 90 days at the same website.

About SYN-004 (ribaxamase) and the Phase 2b Study

SYN-004 (ribaxamase) is a first-in-class oral enzyme 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 CDI, AAD and the emergence of antibiotic-resistant organisms. The Phase 2b proof-of-concept clinical trial is intended to evaluate the effectiveness of ribaxamase to prevent the onset of primary C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms in patients hospitalized with a lower respiratory infection and receiving IV ceftriaxone. A total of 412 subjects were randomized in a 1:1 ratio receiving either 150 mg dose strength of SYN-004 (ribaxamase) or placebo orally QID from Day 1 and until 72 hours following their last treatment of IV ceftriaxone. The sample size was determined to provide 80% power to detect the treatment effect with a one-sided alpha of 0.05. P-values were determined based on a 1-sided z-test for the comparison of the treatment difference as pre-specified in the statistical analysis plan. To access the ribaxamase mechanism of action video on Synthetic Biologics’ website, please click here.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients. The Company’s lead candidates poised for Phase 3 development are: (1) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C), and (2) SYN-004 (ribaxamase) which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection, antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms. The Company is also developing preclinical stage monoclonal antibody therapies for the prevention and treatment of pertussis and novel discovery stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 and include statements regarding the potential of ribaxamase to help address the serious health impacts associated with CDI and infections from other opportunistic bacteria resulting from dysbiosis of the gut microbiome, the industry data regarding the expected incidence and economic burden of CDI, the potential of ribaxamase to shorten hospital stays, diminish morbidity and mortality and reduce the emergence of antibiotic resistant organisms in the gut microbiome by protecting patients from primary C. difficile infection resulting from IV antibiotic use, the potential to reduce the economic burden to the healthcare system from an effective therapeutic, the suggested trend toward a reduction of incidence of antibiotic-associated diarrhea from all causes, the expected timing of data release of exploratory endpoints of the trial focused on the ability of ribaxamase to prevent the emergence of antibiotic-resistant organisms in the gut microbiome, the continued ongoing discussions with the FDA and CDC, validation for our approach to advancing cutting edge microbiome science, the continued preparation  for the initiation of pivotal Phase 2b/3 clinical trials for SYN-010, the potential of the drug class to address serious diseases and public health concerns, the ability of SYN-004 to protect the gut microbiome from the effects of certain commonly used IV beta-lactam antibiotics for the prevention of  C. difficile infection, antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of 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 current expectations include, among others, Synthetic Biologics’ product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, Synthetic Biologics’ ability to initiate clinical trials and if initiated, to complete them on time and achieve desired results and benefits, Synthetic Biologics’ clinical trials continuing enrollment as expected, Synthetic Biologics’ ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Synthetic Biologics’ ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of Synthetic Biologics’ products by competitors that render Synthetic Biologics’ products obsolete or non-competitive, Synthetic Biologics’ ability to maintain its license agreements, the continued maintenance and growth of Synthetic Biologics’ patent estate, Synthetic Biologics becoming and remaining profitable, Synthetic Biologics’ ability to establish and maintain collaborations, Synthetic Biologics’ ability to obtain or maintain the capital or grants necessary to fund its research and development activities, a loss of any of Synthetic Biologics’ key scientists or management personnel, and other factors described in Synthetic Biologics’ Annual Report on Form 10-K for the year ended December 31, 2015 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K.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.

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

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/synthetic-biologics-syn-004-ribaxamase-achieves-primary-endpoint-in-phase-2b-trial-for-c-difficile-infection-cdi-300386140.html

SOURCE Synthetic Biologics, Inc.

Rebiotix Treats First Patient In Phase 1 Study of RBX7455 Oral Capsule – A Formulation of Rebiotix’s Microbiota Restoration Therapy (MRT)

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Rebiotix Treats First Patient in Phase 1 Study of RBX7455, an Orally Delivered Broad-Spectrum Non-Frozen MicrobiotaROSEVILLE, Minn., Jan. 4, 2017

 

Rebiotix Inc., a clinical-stage biotechnology company focused on harnessing the power of the human microbiome to treat challenging diseases, announced today that the first patient has been treated in a Phase 1 study of RBX7455 for the prevention of recurrent Clostridium difficile (C. diff.) infection.

RBX7455 is a lyophilized non-frozen oral capsule formulation of Rebiotix’s Microbiota Restoration Therapy (MRT), a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format.

RBX7455 lyophilized capsules remove the need for patients to keep the product frozen or refrigerated.

This prospective, single center, two-arm Phase 1 study is a proof of concept dosing study of RBX7455 for the prevention of recurrent C. diff. infection, an increasingly difficult-to-resolve intestinal infection that causes approximately 29,000 deaths in the U.S. each year.1 It is also the first clinical study of an oral microbiota therapy that allows the patient to take the medication at home.

  • RBX7455 requires no special handling or storage needs for patients. The study will enroll approximately 20 patients at a single U.S. site and is being conducted by the Mayo Clinic, a nonprofit worldwide leader in medical care, research and education.

“New therapies are urgently needed to prevent recurrent C. diff., a debilitating, costly and potentially life-threatening infection,” said Dr. Sahil Khanna, Assistant Professor of Medicine, Department of Gastroenterology and Hepatology, Mayo Clinic, who is leading the study. “RBX7455 not only provides standardized and stabilized human microbes orally, but may provide several advantages in terms of patient dosing and therapy accessibility since no freezing or refrigeration is needed when the patient takes the product home.”

The initiation of the Phase 1 study of RBX7455 enhances Rebiotix’s clinical pipeline of human microbiome-directed drug candidates. The Company’s lead drug candidate, RBX2660, recently completed a Phase 2b randomized, double-blind placebo-controlled trial examining the efficacy and safety of the microbiota restoration therapeutic as a prevention for recurrent C. diff. infection after a standard of care course of antibiotics (PUNCH™ CD2).

“Dosing the first patient in the Phase 1 study of RBX7455 is a significant milestone for Rebiotix as it solidifies our position as the most clinically advanced microbiome company in the industry, while showcasing the potential of our MRT platform to create new solutions for challenging diseases through standardized microbiota-based drug development,” stated Lee Jones, president and CEO of Rebiotix. ”

RBX7455 is a potentially ground-breaking product for Rebiotix and the entire microbiome industry in that the lyophilized oral capsules do not need to be kept frozen and thus can be stocked in a pharmacy with no special handling or storage needs. As such, RBX7455 offers the unique opportunity to introduce live microbial therapy as a potential treatment for numerous diseases where chronic or repeat dosing is required.”

To read the article in its entirety please click on the following link to be redirected
*Please note – The C Diff Foundation does not endorse any products and/or clinical study in progress. All website postings are strictly for informational purposes only. Thank You.

Infection Prevention – Patient Safety – Prior And During A Hospital Stay

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This is a patient – safety article and quite informative and beneficial for everyone.  The topics are highlighted on how to prevent infections prior and during a hospital stay.

 

The most pertinent information to review and share with others is as follows:

1. Check Up on Your Hospital
See how it compares with others on central line, C. diff, and MRSA infections, as well as other measures of patient safety. To compare hospitals in your area at preventing infections, use our hospital ratings.

2. Have a Friend or Family Member With You
That person can act as your advocate, ask questions, and keep notes. A Consumer Reports survey of 1,200 recently hospitalized people found that those who had a companion were 16 percent more likely to say that they had been treated respectfully by medical personnel. The most important times to have a companion for preventing infections and other medical errors are on nights, weekends, and holidays, when staff is reduced, and when shifts change.

3. Keep a Record
Keep a pad and pen nearby so that you can note what doctors and nurses say, which drugs you get, and questions you have. If you spot something worrisome, such as a drug you don’t recognize, take a note or snap a picture on your phone. You can also use your phone to record thoughts or conversations with staff. Though some may object, “explain that you are recording so you remember later,” McGiffert says.

4. Insist on Clean Hands
Ask everyone who enters your room whether they’ve washed their hands with soap and water. Alcohol-based hand sanitizer is not enough to destroy certain bacteria, such as the dangerous C. diff. Don’t hesitate to say: “I’m sorry, but I didn’t see you wash your hands. Would you mind doing it again?”

https://cdifffoundation.org/hand-washing-updates/

 

5. Keep It Clean
Bring bleach wipes for bed rails, doorknobs, the phone, and the TV remote, all of which can harbor bacteria. And if your room looks dirty, ask that it be cleaned.

6. Cover Wounds
Some hospitals examine incisions daily for infection, but opening the bandage exposes the area to bacteria. Newer techniques—sealing the surgical site with skin glue (instead of staples, which can harbor bacteria) and waterproof dressings that stay on for one to three weeks without opening—are effective at preventing infection.

7. Inquire Whether IVs and Catheters Are Needed
Ask every day whether central lines, urinary catheters, or other tubes can be removed. The longer they’re left in place, the greater the infection risk.

8. Ask About Antibiotics
For many surgeries, you should get an antibiotic 60 minutes before the operation. But research suggests that the type of antibiotic used or the timing of when it’s administered is wrong in up to half of cases.

Listen to one of the educational Podcasts:  Using antibiotics wisely, How to help in the fight against antibiotic resistance  with Guests Dr. Arjun Srinivassan, MD and Dr. Lauri Hicks, DO

https://www.voiceamerica.com/episode/93656/encore-using-antibiotics-wisely-how-you-can-help-in-the-fight-against-antibiotic-resistance

9. Postpone Surgery If You Have an Infection
That increases your risk of developing a new infection and worsening an existing one. So if you have any other type of infection—say, an abscessed tooth—then the surgery should be postponed, if possible, until it’s completely resolved.

10. Say No to Razors
Removing hair from the surgical site is often necessary, but doing that with a regular razor can cause nicks that provide an opening for bacteria. The nurse should use an electric trimmer instead.

11. Question the Need for Heartburn Drugs
Some patients enter the hospital taking heartburn drugs such as Nexium, lansoprazole (Prevacid) or omeprazole (Prilosec) or are prescribed one after they’re admitted. But these drugs, called proton-pump inhibitors, increase the risk of intestinal infections and pneumonia, so consider stopping them before admission and, once there, ask whether you really need one.

12. Test for MRSA
Ask your surgeon to screen you for MRSA, a potentially deadly bacteria that’s resistant to antibiotics, either before you enter or on admission, so that you can address the problem and hospital staff can take extra steps to protect you and others.

13. Watch for Diarrhea
Get tested for C. diff. infection  if you have three loose stools within 24 hours. If you test positive, expect extra precautions for preventing infections from spreading to others.

14. Quit Smoking, Even Temporarily
You won’t be allowed to smoke in the hospital anyway, and stopping as long as possible beforehand cuts the risk of infection. Read our advice on how to stop smoking.

15. Wash Up the Night Before Surgery
Ask about taking precautions before entering the hospital, such as bathing with special soap or using antiseptic wipes.

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

Rebiotix Is Issued U.S. Patent For Its Patent Application Entitled “Microbiota Restoration Therapy (MRT) Compositions and Methods Of Manufacture”

Rebiotix Inc., a clinical-stage biotechnology company focused on harnessing the power of the human microbiome to treat challenging diseases,  announced on October 11, 2016 that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 9,433,651 to Rebiotix for its patent application entitled, “Microbiota Restoration Therapy (MRT), Compositions and Methods of Manufacture.” The patent covers Microbiota Restoration Therapy (MRT) compositions and methods for manufacturing, processing and delivering the compositions, and builds on Rebiotix’s patent issuances in Australia and Canada.

MRT is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a readyto-use and easy-to-administer format. The patented technology is based on ground-breaking work that provides an avenue for the treatment of a variety of diseases including Clostridium difficile (C.diff), ulcerative colitis, hepatic encephalopathy and multi-drug resistant organisms.

“This patent covering our MRT platform is a significant addition to Rebiotix’s IP estate as we continue to advance our industry-leading pipeline of microbiome-directed drug therapies, including RBX2660, our Phase 3-ready drug candidate,” stated Lee Jones, Chief Executive Officer of Rebiotix. “Rebiotix has established one of the deepest IP portfolios in the microbiome industry covering an array of subjects, from formulation and storage to delivery and disease targets, that we believe are key to the eventual commercialization of microbiota-based therapeutics.”

https://cdifffoundation.org/clinical-trials-2/

 

About Rebiotix Inc.

Rebiotix Inc. is a clinical-stage biotechnology company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix is the most clinically advanced microbiome company in the industry, with its Phase 3-ready drug candidate, RBX2660, having successfully completed a Phase 2b randomized, double-blind, placebo controlled trial as a potential treatment for recurrent Clostridium difficile infection (PUNCH™ CD2). RBX2660 has been granted Orphan Drug status, Fast Track status and Breakthrough Therapy Designation from the FDA for its potential to treat recurrent C. diff. infection.

Rebiotix’s development pipeline includes multiple formulations targeting several disease indications and is built around its pioneering Microbiota Restoration Therapy (MRT) platform. MRT is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com.

source:  Rebiotix

Centers for Disease Control and Prevention (CDC) Provides Updates On C. difficile Infection Management and Treatment

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According to the Centers for Disease Control and Prevention (CDC), Clostridium difficile infection (C. difficile) “has become the most common microbial cause of healthcare-associated infections in U.S. hospitals and costs up to $4.8 billion each year in excess health care costs for acute care facilities alone.”

Statistics provided by the CDC suggest that C. difficile cause nearly 500,000 infections in patients in the US annually.

In one study noted by the CDC, among infected patients, nearly 29,000 died within 30 days of being diagnosed, and more than half of those deaths (15,000) were directly attributable to C. difficile infection.

With C. difficile infection prevention being declared a national priority by the CDC, researchers, public health officials, infectious disease specialists, and others continue to research more effective ways to combat this microbe. Below, we’ve collected links and information on several recent developments.

THE GOOD NEWS
The Center for Infectious Disease Research and Policy (CIDRAP) recently -hospital-stewardship-lowers-antibiotic-use-infections”>reported some good news about the effectiveness of antibiotic stewardship programs (ASPs) in reducing antibiotic usage, especially among patients in the intensive care unit.

Citing the results of a meta-analysis published in Antimicrobial Agents and Chemotherapy, the CIDRAP report noted that, following the implementation of an ASP, “hospital antimicrobial consumption across all studies declined by 19.1%, and antibiotic costs fell by 33.9%. Though a modest decrease of 12.1% in antimicrobial use occurred in general medical wards, antimicrobial use in ICUs fell by 39.5% across the four studies that looked at that parameter.”

The meta-analysis also found that ASPs were effective in curbing the use of non-antibiotic therapies. In the six studies that also monitored antifungal prescription rates, the authors reported a 39.1% decline after ASP initiation.

The use of third- and fourth generation antibiotics (such as cephalosporins, vancomycin, tigecycline, linezolid, imipenem, meropenem, and fluoroquinolones) declined by 26.6% in facilities that implemented an ASP.

The meta-analysis found that bacteria infection rates declined 4.5% in the studies that measured clinical outcomes, and length of hospital stay fell by nearly 9% in studies that measured that metric.

However, the CIDRAP report noted that ASP implementation was not “associated with declining risks for Clostridium difficile (C diff) infections.” The authors of the meta-analysis did note that, in three studies that evaluated C difficile rates, “significant publication bias favored studies that reported ASPs’ negative effects.”

Let’s just get right to the heart of this report from Reuters:

“Fifteen years after the U.S. government declared antibiotic-resistant infections to be a grave threat to public health, a Reuters investigation has found that infection-related deaths are going uncounted, hindering the nation’s ability to fight a scourge that exacts a significant human and financial toll. Even when recorded, tens of thousands of deaths from drug-resistant infections – as well as many more infections that sicken but don’t kill people – go uncounted because federal and state agencies are doing a poor job of tracking them.

The Centers for Disease Control and Prevention (CDC), the go-to national public health monitor, and state health departments lack the political, legal and financial wherewithal to impose rigorous surveillance.”

The report goes on to outline how incomplete, “patchwork” infection reporting requirements for hospitals, and lax requirements in many states regarding physicians’ responsibilities when filling out death certificates, have led to deaths caused by (or at the very least associated with) MRSA and other drug-resistant pathogens to be “grossly under-reported.”

For example, according to Reuters, only 17 states require notification of C. difficile infections. Only two of the so-called “superbug” infections (MRSA bacteremia and C. difficile) are required to be reported to the CDC’s National Healthcare Safety Network surveillance program.

As they say, read the whole thing.

The authors of an article published in Clinical Microbiology and Infection  reported on a study that compared treatment with tigecycline to standard therapy in adult patients with severe C. difficile infection (sCDI).

The retrospective cohort study compared outcomes in patients with sCDI who received tigecycline alone to outcomes in patients who received standard oral vancomycin combined with intravenous metronidazole.

The primary study outcome was clinical recovery (as determined by European Society of Clinical Microbiology and Infectious Diseases guidelines); secondary outcomes were “in-hospital and 90-day all-cause mortality and relapse, colectomy and complication rates.”

A total of 90 patients with sCDI were treated (45 in each group). Patients treated with tigecycline monotherapy tended to do better in terms of cure rate, complicated disease, and CDI sepsis.

The authors reported that, compared to the group that received standard therapy, the tigecycline group had “significantly better outcomes of clinical cure (34/45, 75.6% vs. 24/45, 53.3%; p=0.02), less complicated disease course (13/45, 28.9% vs. 24/45, 53.3%; p=0.02) and less CDI sepsis (7/45, 15.6% vs. 18/45, 40.0%; p=0.009).”

Rates of mortality, disease relapse, and other measures were similar between the groups.

These results led the researchers to conclude that “tigecycline might be considered as a potential candidate for therapeutic usage in cases of sCDI refractory to standard treatment.”

Our good friends at Contagion Live recently reported on a study that has uncovered how the C. difficile bacteria produces toxins, which could aid the development of nonantibiotic drugs to fight C. difficile infection.

According to Contagion Live, C. difficile produces two toxins, toxin A and toxin B, that “cause life-threatening diarrhea as well as pseudomembranous colitis, toxic megacolon, perforations in the colon, sepsis and rarely death.”

Researchers at the University of Texas found that strains of C. difficile with a mutation in a particular Agr locus in their genome could not produce the toxins.

“Identifying a pathway responsible for activating the production of the toxins… opens up a unique therapeutic target for the development of a novel nonantibiotic therapy for C. difficile infections,” said the study authors.

The Contagion Live article includes a quote from author Charles Darkoh, PhD, on the potential implications of these findings.

“By crippling their toxin-making machinery, C. diff cannot make toxins and thus cannot cause disease. My laboratory is already working on this and was awarded a 5-year National Institutes of Health grant to investigate and develop an oral compound we have identified that inactivate the toxins and block the toxin-making machinery of C. diff by targeting this pathway,” he said.

 

 

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

 http://www.hcplive.com/medical-news/latest-news-and-updates-on-c-difficile-infection-management-and-treatment/P-4#sthash.iDm6FgAP.dpuf

 

Learn More About The Signs and Symptoms Of Sepsis With The CDC; It’s A Race Against Time

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Saving patients from sepsis is a race against time

CDC calls sepsis a medical emergency; encourages prompt action for prevention, early recognition

Sepsis is caused by the body’s overwhelming and life-threatening response to an infection and requires rapid intervention. It begins outside of the hospital for nearly 80 percent of patients. According to a new Vital Signs report released by CDC, about 7 in 10 patients with sepsis had used health care services recently or had chronic diseases that required frequent medical care. These represent opportunities for healthcare providers to prevent, recognize, and treat sepsis long before it can cause life-threatening illness or death.

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“When sepsis occurs, it should be treated as a medical emergency,” said CDC Director Tom Frieden, M.D., M.P.H. “Doctors and nurses can prevent sepsis and also the devastating effects of sepsis, and patients and families can watch for sepsis and ask, ‘could this be sepsis?’”   

Certain people with an infection are more likely to get sepsis, including people age 65 years or older, infants less than 1 year old, people who have weakened immune systems, and people who have chronic medical conditions (such as diabetes). While much less common, even healthy children and adults can develop sepsis from an infection, especially when not recognized early. The signs and symptoms of sepsis include: shivering, fever, or feeling very cold; extreme pain or discomfort; clammy or sweaty skin; confusion or disorientation; shortness of breath and a high heart rate.

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According to the Vital Signs report, infections of the lung, urinary tract, skin, and gut most often led to sepsis. In most cases, the germ that caused the infection leading to sepsis was not identified. When identified, the most common germs leading to sepsis were Staphylococcus aureus, Escherichia coli (E. coli), and some types of Streptococcus.

 

Health care providers, patients and their family members can work as a team to prevent sepsis.

Health care providers play a critical role in protecting patients from infections that can lead to sepsis and recognizing sepsis early. Health care providers can:

·         Prevent infections. Follow infection control requirements (such as handwashing) and ensure patients to get recommended vaccines (e.g., flu and pneumococcal).

·         Educate patients and their families. Stress the need to prevent infections, manage chronic conditions, and, if an infection is not improving, promptly seek care. Don’t delay.

·         Think sepsis. Know the signs and symptoms to identify and treat patients earlier.

·         Act fast. If sepsis is suspected, order tests to help determine if an infection is present, where it is, and what caused it. Start antibiotics and other recommended medical care immediately.

·         Reassess patient management. Check patient progress frequently. Reassess antibiotic therapy 24-48 hours or sooner to change therapy as needed. Determine whether the type of antibiotics, dose, and duration are correct.

CDC is working on five key areas related to sepsis:

·         Increasing sepsis awareness by engaging clinical professional organizations and patient advocates.

·         Aligning infection prevention, chronic disease management, and appropriate antibiotic use to promote early recognition of sepsis.

·         Studying risk factors for sepsis that can guide focused prevention and early recognition.

·         Developing tracking for sepsis to measure impact of successful interventions.

·         Preventing infections that may lead to sepsis by promoting vaccination programs, chronic disease management, infection prevention, and appropriate antibiotic use.

To read the entire Vital Signs report visit: www.cdc.gov/vitalsigns/sepsis.

For more information on sepsis and CDC’s work visit: www.cdc.gov/sepsis.

U.S. Department of Health and Human Services

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CDC works 24/7 protecting America’s health, safety and security. Whether diseases start at home or abroad, are curable or preventable, chronic or acute, stem from human error or deliberate attack, CDC is committed to respond to America’s most pressing health challenges.

 

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