Tag Archives: C. diff. news

Recent Emergence of C.difficile Infection in Romanian Hospitals – Abstract

Recent Emergence of Clostridium Difficile Infection in Romanian Hospitals is Associated With a High Prevalence of Polymerase Chain Reaction Ribotype 027.

Abstract

AIMS:

To evaluate the epidemiology of Clostridium difficile infection in several Romanian hospitals.

METHODS:

A survey was conducted from November 2013 to February 2014 in 9 hospitals selected from different Romanian regions.

RESULT:

The survey identified 393 patients with C. difficile infection. The median age was 67 years (range: 2-94 years) with 56% of patients older than 65 years. The mean C. difficile infection prevalence was 5.2 per 10.000 patient-days, with the highest prevalence, 24.9 and 20 per 10.000 patients-days, reported in a gastroenterology and an infectious diseases hospital, respectively. The origin of C. difficile infection was health care-associated for 70.5% of the patients, community-acquired for 10.2% of patients and indeterminate for other 19.3%. Severe C. difficile infection was registred in 12.3% cases and in hospital all-cause mortality was 8.8%. Polymerase chain reaction-ribotype 027 was the most prevalent in all participating hospitals, and represented 82.6% of the total ribotyped isolates. Moxifloxacin minimal inhibitory concentrations were higher than 4 μg/mL for 59 of 80 tested isolates (73.8%). Fifty-four of these 59 isolates were highly resistant to moxifloxacin, (minimal inhibitory concentration ≥32 μg/mL) and belonged more frequently to polymerase chain reaction-ribotype 027 (p<0.0001).

CONCLUSION:

The present study is the first multicentre study performed in Romania and shows that the ribotype 027 is largely predominant in C. difficile infection cases in Romania. The prevalence of C. difficile infection in some specialized hospitals is higher than the European mean prevalence and demonstrates the need of strict adherence to infection control programmes.

 

https://www.ncbi.nlm.nih.gov/pubmed/29188783?dopt=Abstract&utm_source=dlvr.it&utm_medium=twitter

Seres Therapeutics Focused On Developing Drugs To Treat Diseases Of The Microbiome With First Clinical Program ECOSPOR Research Study In The Treatment Of C. diff. Infection (CDI) And Now Open For Enrollment

seres_logo2_cmykSeres Therapeutics is a clinical-stage therapeutics company focused on discovering and developing drugs to treat diseases of the microbiome. The biology of the microbiome is driven by ecologies—the functional collections of various organisms—which are central to health and disease.

Seres is developing Ecobiotic® therapeutics to treat diseases that have an underlying microbiome biology. Seres Therapeutic’s first clinical program, The ECOSPOR Research study is in the treatment of Clostridium difficile  infection (CDI).
About The ECOSPOR Research Study

Although antibiotics are used to treat recurrent C. difficile infection, most of the time they do not cure C. difficile. In addition, antibiotics continue to wipe out the good bacteria that protect you against C. difficile. Currently, there are no medications available that can prevent this infection from coming back when your gut is defenseless.

SER-109 is an investigational medicine being developed to prevent recurrent C. difficile from coming back again. The idea is to first treat patients with antibiotics that work against C. difficile so that the diarrhea goes away. Then patients may get SER-109 to keep the C. difficile infection from coming back.

In the ECOSPOR study, doctors will compare SER-109 to a placebo pill, which looks like SER-109. However, the placebo pill will have no medication inside it. Patients will be randomly assigned to receive either SER-109 or placebo. The study is designed to provide more information about the potential safety and effectiveness of SER-109, and will last about 7 months. The results will help doctors and researchers learn whether SER-109 could one day be used to prevent recurrent CDI.

The ECOSPOR Study is now open for enrollment. If you would like more information the study is posted on ClinicalTrials.gov.

You can all contact clinicalstudies@sereshealth.com or by calling  1-617-945-9626  (USA) to find a doctor near you who is involved in the study.

 

 

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

ROCHE cobas® C. diff. Test approved by US Food and Drug Administration (FDA)

laboratorystillUS Food and Drug Administration (FDA) has provided 510(k) clearance for the cobas® Cdiff Test to detect Clostridium difficile (C. difficile) in stool specimens.

The cobas® Cdiff Test targets the toxin B gene found in toxigenic C. difficile strains directly in specimens from symptomatic patients. The test provides accurate information which assists clinicians in making timely treatment decisions and aids in the prevention of further infection in healthcare settings.

“Having the ability to provide a result quickly is important when supporting infection control for Clostridium difficile,” said Dr. Steve Young, Professor of Pathology, Department of Pathology UNMHSC and Tricore Reference Lab. “The cobas® 4800 System has the capability to allow for mixed batch testing of the cobas® Cdiff Test alongside testing for Methicillin-resistant Staphylococcus aureus, Staphylococcus aureus, and herpes simplex virus 1 and 2*, all on one platform. We can run these assays together at least once in each shift rather than once a day, which can greatly improve laboratory efficiency, ultimately leading to better infection control and patient care.”

In a clinical trial program conducted at sites throughout the United States, the cobas® Cdiff Test demonstrated excellent performance compared to direct and enrichment toxigenic culture. The test combines high assay sensitivity with rapid turnaround time and a minimum number of pre-analytic steps, to facilitate earlier intervention of patients suffering from

C. difficile-associated disease. Earlier intervention can also lead to more effective implementation of infection control measures, which can prevent further transmission to additional patients.

About the cobas® 4800 System
The cobas® 4800 System offers true walk-away automation of nucleic acid purification, PCR set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The expanding system menu in the U.S. currently includes the cobas® MRSA/SA Test, cobas® CT/NG Test (Chlamydia trachomatis/Neisseria gonorrhoeae), cobas® HPV Test, cobas® BRAF V600 Mutation Test, cobas® EGFR Mutation Test and cobas® KRAS Mutation Test.

“With the addition of the cobas® Cdiff Test to the cobas® 4800 System menu, Roche is able to expand the tools available to assist clinicians in the management of healthcare associated infections,” said Paul Brown, head of Roche Molecular Diagnostics. “The cobas® Cdiff Test requires less sample handling and provides laboratories with a simplified workflow, when compared to other molecular methods. It also delivers a lower inhibition rate, which means fewer repeat samples and chances for error, enabling better patient care.”

 

To access the news article:

http://finance.yahoo.com/news/roche-receives-fda-clearance-cobas-050000123.html

 

C. diff. – New CDC Study – National Burden of Clostridium difficile (C. diff.) Infections

Nearly half a million Americans suffered from Clostridium difficile (C. diff.) infections in a single year according to a study released today, February 25, 2015, by the Centers for Disease Control and Prevention (CDC).

• More than 100,000 of these infections developed among residents of U.S. nursing homes.
Approximately 29,000 patients died within 30 days of the initial diagnosis of a C. diff. infection. Of these 29,000 – 15,000 deaths were estimated to be directly related to a
C. diff. infection. Therefore; C. diff. is an important cause of infectious disease death in the U.S.
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. Approximately
two-thirds of C. diff. infections were found to be associated with an inpatient stay in a health care facility, only 24% of the total cases occurred in patients while they were hospitalized. The study also revealed that almost as many cases occurred in nursing homes as in hospitals and the remainder of individuals acquired the
Healthcare-Associated infection, C. diff., recently discharged from a health care facility.

 

This new study finds that 1 out of every 5 patients with the Healthcare-Associated Infection (HAI), C. diff., experience a recurrence of the infection and 1 out of every 9 patients over the age of 65 diagnosed with a HAI – C. diff. infection died within 30 days of being diagnosed. Older Americans are quite vulnerable to this life-threatening diarrhea infection. The CDC study also found that women and Caucasian individuals are at an increased risk of acquiring a C. diff. infection.

 

CDC Director, Dr. Tom Frieden, MD, MPH said, “C. difficile infections cause immense suffering and death for thousands of Americans each year.” “These infections can be prevented by improving antibiotic prescribing and by improving infection control in the health care system. CDC hopes to ramp up prevention of this deadly infection by supporting State Antibiotic Resistance Prevention Programs in all 50 states.”

 
The Agency for Healthcare Research and Quality (AHRQ) has developed a toolkit to help all hospitals begin antibiotic stewardship programs to reduce C. diff. infections.
Based on the National Plan to Prevent Healthcare – Associated Infections: Road Map to Elimination, new 2020 national reduction targets are being established for C. diff. and all hospitals participating in the Centers for Medicare & Medicaid Services (CMS) Hospital Inpatient Quality Reporting Program have been reporting C. diff. infection data to the CDC’s National Healthcare Safety Network since 2013. The baseline data allows for continued surveillance for C. diff. infections to monitor progress in prevention.

 
Improve the use of antibiotics in preventing C. diff. infections:
150,000 of the half a million C. diff. infections – the new study revealed that they were community-associated and had no documented health care exposure. A separate recent CDC study found that 82% of patients with community-associated C. diff. infections reported exposure to outpatient health care settings (e.g., physicians or dentist office) within twelve weeks before being diagnosed with a C. diff. infection. Through this finding confirms the need for infection control in these settings as well and the need for improved antibiotic use. Another recent CDC study showed a 30% decrease in the use of antibiotics lined to a C. diff. infection in hospitals could reduce newly diagnosed infections by more than 25% in hospitalized and recently discharged patients. A new retrospective study being conducted at a Canadian hospital found that a 10% decrease in overall antibiotic usage through different wards was related to a 34% decrease in newly diagnosed C. diff. infections. A third CDC study among patients without a recent hospitalization or nursing home stay (i.e. community-associated cases) found that a 10% reduction in the use of all antibiotics in outpatient settings could reduce newly diagnosed            C. diff. infections by 16%. In recent years England has seen a reduction of newly diagnosed          C. diff. cases by 60% largely due to improvements in antibiotic prescribing.

 
C. diff.; Different strains? The North American pulsed-field gel electrophoresis type 1 (NAP1) strain was more prevalent among healthcare-associated than community-associated infections. Changes in the epidemiology of C. difficile infections have occurred since the emergence of this strain in 2000, which has been responsible for widespread dispersed hospital-associated outbreaks. The NAP1 strain was first detected in Pittsburgh, PA and Montreal and is now global. It is causing the majority of infections in communities and healthcare settings. 30% detected in the study and increase seen in healthcare facilities as it is more easily transmitted. “All organisms producing toxins, all infections – must be looked upon with seriousness.”                          Dr. Michael Bell, MD and Dr. Clifford McDonald, MD both concurred.

 
The diagnosing and detection of a C. difficile infection is at the transition point in how this infection is being diagnosed. There is a need to use better methods of testing and who gets tested and a combination of clinical symptoms and laboratory tests. The Enzyme assay may not be sensitive enough and the PCR is more readily used, is more sensitive, and was used in this study with 50% laboratory producing a C. diff. diagnosis.
The care involved treating a patient with a C. difficile infection begins as a short-term treatment and can develop into a long-term illness with many recurrences.

 
Dr. Michael Bell, MD shared a brief C. diff. infection possible scenario:
• The patient may have been on an antibiotic within 90 days and develops diarrhea, then the individual should see a medical physician and get tested for a C. diff. infection.
• If the test result is positive for a C. diff. infection then treatment begins with a prescribed oral antibiotic.
• It may take multiple rounds of a oral antibiotic to suppress a C. diff. infection.
• There is a challenge treating a C. diff. infection as the antibiotic continually disturbs the bacteria in the bowel.
• Toxic forming C. diff. can put one’s life at risk as leaks develop in the bowel allowing bacteria to enter the blood stream (bacteremia).
• The infection may progress and the physicians may have to perform a surgical procedure and remove part or the entire colon (colectomy).
• Or the progression of a C. diff. infection leads the patient diagnosed with a C. diff. infection into becoming a surgical patient which will change their life through a diversion of the bowel (colostomy).
Ways to prevent C. diff. infection recurrences:
Do not take antibiotics unless absolutely necessary and diagnosed with a infection that a antibiotic will be effective. The use of an antibiotic treating symptoms caused by a virus is not effective. (Antibiotic stewardship).
Make the clinician aware that a antibiotic has been taken to treat a infection.
Antibiotics are lifesaving medications and need to be prescribed correctly to avoid antibiotic-resistance.
Healthcare facilities must implement and maintain Hand-washing (hand-hygiene) programs – Infection control.
Probiotics – are found in foods (e.g., Kefir, Yogurt) and are sold as a nutritional supplement, (1) “The U.S. Food and Drug Administration (FDA) has no definition of probiotics and regulates them based on whether they fall into one of the existing regulated product categories,” says Hoffmann, who along with faculty members from the University of Maryland School of Medicine’s Institute for Genomics Sciences, the University of Maryland School of Pharmacy and the University of Maryland Carey School of Law, investigated how probiotics are being regulated
(1) See more at: http://www.thedailysheeple.com/fda-to-change-regulations-for-probiotics_102013#sthash.4IGLf8aE.dpuf

 

C. diff. spores and outpatient settings: There were C. diff. spores found in outpatient settings. A study done at outpatient clinics found that patients who had recently been treated for a C. diff. infection in a hospital, and discharged continued shedding C. diff. spores from weeks to months after recovering from the infection. Clostridium difficile (C. diff.) spores were found on the exam table and in the clinic exam areas. Based on this information it is beneficial to continue disinfecting hard non-porous surfaces utilizing EPA registered disinfecting products, with C. diff. kill claim, in home-care and within healthcare facilities to continue decreasing the spread of        C. diff. spores and maintain infection control. There are Infection programs ongoing with the CDC with continued monitoring/studies.

 

Preventing C. difficile is a National Priority

Based on the National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination, new 2020 national reduction targets are being established for C. difficile, and all hospitals participating in the Centers for Medicare & Medicaid Services’ (CMS) Hospital Inpatient Quality Reporting Program have been reporting C. difficile infection data to CDC’s National Healthcare Safety Network since 2013. Those baseline data will allow continued surveillance for C. difficile infections to monitor progress in prevention.

The State Antibiotic Resistance Prevention Programs that would be supported by the funding proposed for CDC in the President’s FY16 budget would work with health care facilities in all 50 states to detect and prevent both C. difficile infections and antibiotic-resistant organisms. The FY 16 budget would also accelerate efforts to improve antibiotic stewardship in inpatient and outpatient settings. During the next five years, CDC’s efforts to combat C. difficile infections and antibiotic resistance under the National Strategy to Combat Antibiotic Resistant Bacteria will enhance national capabilities for antibiotic stewardship, outbreak surveillance, and antibiotic resistance prevention. These efforts hold the potential to cut the incidence of C. difficile infections in half.

For more information please click on the link provided below:

http://content.govdelivery.com/accounts/USCDC/bulletins/f3c509?reqfrom=share

C. diff. Radio talk show “C.diff. Spores and More” debuts on Tuesday, March 3rd

What’s new in the C Diff Foundation?

Let us introduce you to the first internet radio talk show dedicated to C. diff. and more……

C. diff. Spores and More”

#Cdiffradio

We invite you to join us in listening to this exciting, new internet talk show when it debuts Tuesday, March 3rd, 2015 at the following times:

ET   2 – 3 p.m.,  CT 1 – 2 p.m.,  MT 12 – 1 p.m.,  PT 11 – 12 p.m.

We are so excited to share the debut of “C. diff. Spores and More” with you – not only because the C Diff Foundation, our Founding Executive Director –  Nancy C. Caralla, and Chairperson of Research and Development – Dr. Chandrabali Ghose, are introducing the first episode, but also because, as advocates of C. diff., we are very excited about what this cutting-edge new weekly radio show means for our Foundation’s community worldwide.

Fact: Deaths and illnesses are much higher than reports have shown. In March, 2012 the  CDC  said in a report that the C difficile infection kills 14,000 people a year. But that estimate is based on death certificates, which often don’t list the infection when patients die from complications, such as kidney failure.  Hospital billing data collected by the federal Agency for Healthcare Research and Quality shows that more than 9% of C. diff-related hospitalizations end in death — nearly five times the rate for other hospital stays. That adds up to more than 30,000 fatalities among the 347,000 C. diff hospitalizations in 2010. Thousands more patients are treated in nursing homes, clinics and doctors’ offices.

“We’re talking in the range of close to 500,000 total cases a year,” says Cliff McDonald, a C. diff expert and senior science adviser in the CDC’s Division of Healthcare Quality Promotion. And annual fatalities “may well be … as high as * 30,000.”

* AHRQ News and Numbers provides statistical highlights on the use and cost of health services and health insurance in the United States.

“This does not include the number of C. diff. infections taking place and being treated in other countries.”  “The  CDF supports hundreds of communities by sharing the CDF mission and    raising C. diff. awareness to healthcare professionals, individuals, patients, families,  and communities working towards a shared goal ~  witnessing a reduction of newly diagnosed            C. diff. cases by 2020 .”   ” The CDF Volunteers are greatly appreciated as they create positive changes sharing their time so generously worldwide aiding in the success of our mission and raising C. diff. awareness.”

C. diff. Spores and More” will spotlight world renown topic experts, research scientists, healthcare professionals, organization representatives, C. diff. survivors, board members, and their volunteers who are all creating positive changes in the C. diff. community and more. Through their interviews, the CDF mission will connect, educate, and empower many in over 180 countries.

Please join us in listening to the first of many episodes of C. diff. Spores and More” debuting on Tuesday, March 3rd .

View the programs and radio information:

health.voiceamerica.com

Take our show on the go…………..download a mobile app today

http://www.voiceamerica.com/company/mobileapps

Clostridium difficile (C.diff.) Testing Development and Validation of an Internationally-Standardized, High-Resolution Capillary Gel-Based Electrophoresis PCR-Ribotyping Protocol

c-diff

Authors:

Abstract

PCR-ribotyping has been adopted in many laboratories as the method of choice for C. difficile typing and surveillance. However, issues with the conventional agarose gel-based technique, including inter-laboratory variation and interpretation of banding patterns have impeded progress.

The method has recently been adapted to incorporate high-resolution capillary gel-based electrophoresis (CE-ribotyping), so improving discrimination, accuracy and reproducibility.

However, reports to date have all represented single-center studies and inter-laboratory variability has not been formally measured or assessed.

Here, we achieved in a multi-center setting a high level of reproducibility, accuracy and portability associated with a consensus CE-ribotyping protocol. Local databases were built at four participating laboratories using a distributed set of 70 known PCR-ribotypes.

A panel of 50 isolates and 60 electronic profiles (blinded and randomized) were distributed to each testing center for PCR-ribotype identification based on local databases generated using the standard set of 70 PCR-ribotypes, and the performance of the consensus protocol assessed.

A maximum standard deviation of only ±3.8bp was recorded in individual fragment sizes, and PCR-ribotypes from 98.2% of anonymised strains were successfully discriminated across four ribotyping centers spanning Europe and North America (98.8% after analyzing discrepancies). Consensus CE-ribotyping increases comparability of typing data between centers and thereby facilitates the rapid and accurate transfer of standardized typing data to support future national and international C. difficile surveillance programs.

 

For article/abstract in its entirety please click on the following link:

http://www.ncbi.nlm.nih.gov/pubmed/25679978?dopt=Abstract