Author Archives: cdifffoundation

What Is SARS-CoV-2 and the Disease It Causes Named coronavirus disease 2019 or Better Known As COVID-19

 

 

 

What is Coronavirus?

The virus has been named “SARS-CoV-2” and the disease it causes has been named “COVID-19.”

Coronaviruses are a large family of viruses that may cause respiratory illnesses in humans ranging from common colds to more severe conditions such as Severe Acute Respiratory Syndrome (SARS) and Middle Eastern Respiratory Syndrome (MERS).

‘Novel coronavirus’ is a new, previously unidentified strain of coronavirus. The novel coronavirus involved in the current outbreak has been named SARS-CoV-2 by the World Health Organization (WHO). The disease it causes has been named “coronavirus disease 2019” (or “COVID-19”).

How does the virus spread?

COVID-19 can spread from person to person usually through close contact with an infected person or through respiratory droplets that are dispersed into the air when an infected person coughs or sneezes.  It may also be possible to get the virus by touching a surface or object contaminated with the virus and then touching your mouth, nose or eyes, but it is not thought to be the main way the virus spreads.

 

 

Where has COVID-19 spread to?

As of the March 6, 2020, there are over 95,000 confirmed cases of infection by the virus—and 3,381 of that number have resulted in death. While most cases of COVID-19 infection are in China, the virus has spread to 88 other countries.

What are the symptoms?

Similar to other respiratory illnesses, the symptoms of COVID-19 may include fever, cough, and shortness of breath.

People infected with COVID-19 may experience any range of these symptoms along with aches and pains, nasal congestion, runny nose, sore throat and diarrhea. Symptoms can start to show up anywhere from two to 14 days after exposure to the virus3. It may be possible for an infected person who is not yet showing any symptoms to spread the virus. Older persons, and those with pre-existing medical illnesses like heart disease and diabetes, however, seem to be more likely to experience severe respiratory symptoms and complications.

How to protect yourself from coronavirus

The best preventative action is to avoid being exposed to the virus. You can do this by taking a few cautionary steps—the same as you would if you were trying to avoid getting any respiratory illness.

  1. Wash your hands with soap and water frequently. If soap and water are not readily accessible, use alcohol-based sanitizers.
  2. Avoid contact with sick people.
  3. Avoid touching your eyes, nose, and mouth with your hands if they are unwashed.
  4. Cover your mouth and nose with a tissue or your bent elbow when you sneeze or cough. Make sure to dispose of the tissue immediately.
  5. If you are feeling unwell, stay home.
  6. If you have no respiratory symptoms such cough, a medical mask is not necessary.  Only use the mask if you have symptoms such as coughing or sneezing or suspect a COVID-19 infection. A mask is recommended for those caring for anyone with COVID-19.

What to do if you suspect you are infected?

The symptoms of COVID-19 are very similar to those of a cold or the flu, making it challenging to identify the specific cause of any respiratory symptoms. If you suspect you have been infected by COVID-19, you should seek medical care as soon as possible.

Until you can access medical care, you should follow these guidelines to reduce your likelihood of infecting others:

  • Restrict your outdoor activities and stay at home as much as you can. If it is feasible, stay in a separate room, and use a different bathroom from others in your household.
  • Clean and/or disinfect objects and surfaces that you touch regularly.
  • Track your symptoms as accurately as possible, so you can provide medical personnel with useful information.

Are there any treatments or vaccines?

There are currently no treatments, drugs, or vaccines available to treat or prevent COVID-19. People infected with the virus should receive medical treatment to relieve and alleviate the symptoms they are experiencing.

For Additional Information Please Visit the CDC Website:

https://www.cdc.gov/coronavirus/2019-ncov/about/index.html

 

Resource:  https://www.gethealthystayhealthy.com/articles/what-know-about-coronavirus-covid-19-explained

The Food and Drug Administration (FDA) Informs Health Care Providers and Patients of the Potential Risk of Transmission of SARS-CoV-2 Virus and COVID-19 By the Use of Fecal Microbiota for Transplantation (FMT)

The global public health community is responding to a rapidly evolving pandemic of respiratory disease caused by a novel coronavirus that was first detected in China.

 

The virus has been named “SARS-CoV-2” and the disease it causes has been named “COVID-19.”

The Food and Drug Administration (FDA) is informing health care providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT) and that FDA has determined that additional safety protections are needed.

Summary of the Issue

Several recent studies have documented the presence of SARS-CoV-2 ribonucleic acid (RNA) and/or SARS-CoV-2 virus in stool of infected individuals.1,2,3 This information suggests that SARS-CoV-2 may be transmitted by FMT, although the risk of such transmission is unknown.4 At this time, testing nasopharyngeal specimens from stool donors for SARS-CoV-2 may not be widely available. Furthermore, there is limited information on the availability and sensitivity of direct testing of stool for SARS-CoV-2.

Additional Protections for the Use of FMT

At this time, FDA is advising that clinical use of FMT has the potential to transmit SARS-CoV-2, whether used as part of a study under an Investigational New Drug Application (IND) on file with the FDA or under FDA’s enforcement discretion policy. To address the risk, stool used for FMT should have been donated before December 1, 2019. Due to the potential for serious adverse events to occur, FDA has determined that the following protections are needed for any use of FMT that is found to be necessary for clincal care if it involves stool donated after December 1, 2019:

  • Donor screening with questions directed at identifying donors who may be currently or recently infected with SARS-CoV-2;
  • Testing donors and/or donor stool for SARS-CoV-2, as feasible;
  • Development of criteria for exclusion of donors and donor stool based on screening and testing; and
  • Informed consent that includes information about the potential for transmission of SARS-CoV-2 via FMT, including FMT prepared from stool from donors who are asymptomatic for COVID-19.

Actions

FDA is in the process of notifying IND holders of the potential risk of transmission of SARS-CoV-2 via FMT and of FDA’s determination that additional safety protections that are needed.

FDA is communicating this information with this statement to all other stakeholders to ensure that everyone is fully informed.

As the scientific community learns more about SARS-CoV-2 and COVID-19, FDA will provide further information as warranted.

Information for Health Care Providers and Patients on Enforcement Discretion

In July 2013, FDA issued a guidance document stating that it intends to exercise enforcement discretion under limited conditions regarding the IND requirements for the use of FMT products to treat C. difficile infection in patients that have not responded to standard therapies. The guidance states that FDA intends to exercise enforcement discretion provided that the treating physician obtains adequate consent for the use of FMT from the patient or his or her legally authorized representative. The consent should include, at a minimum, a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks.

Reporting Adverse Events

FDA encourages all health care providers and patients to report any suspected adverse events or side effects related to the administration of FMT products to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

 


1 Xiao F, Tang M, Zheng X, Liu Y, Li X, Shan H, Evidence for gastrointestinal infection of SARS-CoV-2, Gastroenterology (2020), doi: https://doi.org/10.1053/j.gastro.2020.02.055External Link Disclaimer
2 Tang A, Tong Z-d, Wang H-l, Dai Y-x, Li K-f, Liu J-n, et al. Detection of novel coronavirus by RT-PCR in stool specimen from asymptomatic child, China. Emerg Infect Dis. (2020), https://doi.org/10.3201/eid2606.200301External Link Disclaimer from https://wwwnc.cdc.gov/eid/article/26/6/20-0301_article
3 Wang, W, Xu, Y, Gao, R, et al., Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA (2020), https://doi.org/10.1001/jama.2020.3786External Link Disclaimer
4 Gu J, Han B, Wang J, COVID-19: Gastrointestinal manifestations and potential fecal-oral transmission, Gastroenterology (2020), doi: https://doi.org/10.1053/j.gastro.2020.02.054

Making a Difference – Innovations in Infection Prevention 2020 Awards

Awards Announcement:

Making a Difference – Innovations in Infection Prevention 2020

C Diff Foundation acknowledges the following organizations “Making a Difference”
In the Infection Prevention community, with their innovative products, services, and
technologies addressing infection prevention.

 

 

 

 

Applied Silver
Innovation: SilvaClean® Technology
SilvaClean chemistry is EPA-approved as a laundry additive with residual activity
against post-laundry contamination.
The SilvaClean system is a dispensing device enabled by the Internet of Things (IoT)
that doses the EPA-approved SilvaClean chemistry onto textiles, leaving fabrics with
residual antimicrobial properties even after laundering (e.g. in storage, during handling
and in use).
http://www.appliedsilver.com/

 

 

 

 

Intellego Technologies
Innovation: UVC Dosimeter™
Able to measure specific wavelengths of UVC radiation.
Can be correlated with a log reduction of microbiology samples e.g. MRSA and C. diff.
Proven functionality through hospital testing.
http://intellego-technologies.com/

 

 

 

 

Synexis Biodefense Systems
Innovation: Synexis™ Microorganism Reduction Systems
Patented Dry Hydrogen Peroxide (DHP) technology uses a building’s ambient humidity
and oxygen to continuously achieve sustainable reduction of microbial challenges from
viruses, bacteria, and mold in the air and on workplace surfaces.
DHP technology is inexpensive, highly scalable, and can be installed standalone or in
existing HVAC systems.
https://synexis.com/

Join Us in November!

Join Us at the 8th Annual International C. diff. Conference and Health EXPO taking
place in Boston, Massachusetts USA on November 12th and 13th, 2020 where we will
present and showcase these prestigious awards to the 2020 “Making a Difference” Innovations In Infection Prevention organizations.

Early Bird Registration is in progress — save over 20% until June 2020.

Congratulations to the organizations dedicated in preventing infections and for
developing products, services, and technology capable to ward off harmful bacteria in
all areas of health care and commercial environments. We are truly grateful for the
innovative measures taken to accomplish this goal.

 

 

C Diff Foundation, a 501(c) (3) non-profit organization, established in 2012, and
comprised of 100% volunteering professionals dedicated at supporting public health
through education and advocating for C. difficile infection (CDI) prevention, treatments,
clinical trials, diagnostics, and environmental safety worldwide.

 

(Disclaimer: C Diff Foundation declares no conflict of interest; no funds or influence
were provided to C Diff Foundation by any parties.)

 

C Diff Foundation Welcomes Teena Chopra, MD, MPH – Clinician Educator

We are pleased to welcome Teena Chopra, MD, MPH, Clinician Educator as a Member of the C Diff Foundation, Co.-Director of the Junior Infection Fighter Program – Infection Prevention Education.

Dr. Chopra is a Professor of Medicine in the Division of Infectious Diseases, at Wayne State University and the Corporate Medical Director of Hospital Epidemiology, Infection Prevention and Antibiotic Stewardship at Detroit Medical Center, Wayne State University. Her research interests include Epidemiology of Healthcare-associated Infections, Infection Prevention Antibiotic Stewardship and Immunization.

Dr. Chopra has published over 70 papers in various journals and book chapters. Additionally she has independently reviewed over 50 journal articles, and  has a special interest in studying the epidemiology of infections, including Clostridium difficile and Multi-Drug Resistant Organisms.

C Diff Foundation Welcomes Maureen Spencer, RN, M.Ed, CIC

We are pleased to welcome Maureen Spencer as a Member of the C Diff Foundation, Co.-Director of the Junior Infection Fighter Program – Infection Prevention Education.

Maureen Spencer, RN, M.Ed. has been an Infection Preventionist for over 40 years and is certified in infection control (CIC). As one of the early pioneers in infection control, she was awarded the APIC National Carole DeMille Award in 1990 and was selected as one of the APIC Heroes of Infection Prevention in 2007. In 2012 she was selected as one of the “Who’s Who of Infection Prevention” and in 2017 was recognized as a Fellow of the Association for Professionals in Infection Control and Epidemiology (FAPIC) for her advanced practice in infection prevention and leader within the field. She is currently an independent Infection Preventionist Consultant from Boston, MA and offers consulting and lecture presentations.Maureen has published numerous peer-reviewed publications and has presented many abstracts/posters at national conference. She is a national and international speaker on an array of infection prevention and control topics. Her previous positions included Director, Clinical Education at Accelerate Diagnostics, Tucson, AZ; Corporate Director, Infection Prevention for Universal Health Services, King of Prussia, PA; Infection Control Manager at New England Baptist Hospital (an Orthopedic Center of Excellence in Boston) and Director of the Infection Control Unit at Mass General Hospital, Boston, MA.

US Food and Drug Administration (FDA) Issued a Safety Alert About Potential Risks of Serious, Even Life-Threatening Infections Linked To Fecal Microbiota Transplantation (FMT)

The US Food and Drug Administration (FDA) yesterday issued a safety alert about the potential risk of serious, even life-threatening, infections linked to fecal microbiota transplantation (FMT) after six patients were infected with diarrhea-causing Escherichia coli following the procedure.  March 13, 2020

According to the alert, two patients developed enteropathogenic E coli (EPEC) infections, and four developed Shiga toxin–producing E coli (STEC), after receiving FMT for Clostridoides difficile infection. Four of the six patients required hospitalization.

“FDA is informing patients and healthcare providers of the potential risk of transmission of pathogenic bacteria by FMT products and the resultant serious adverse reactions that may occur,” the agency said. “Patients considering FMT for the treatment of C. difficile infection should speak to their health care provider to understand the associated risks.”

STEC is a pathogenic form of E coli that causes abdominal pain, bloody diarrhea, vomiting, and mild fever. EPEC generally doesn’t cause any symptoms, but some strains can cause diarrhea.

Change in screening protocols

The stool used in the procedures all came from Boston-based OpenBiome, the country’s largest stool bank. The company said in a press release yesterday that the cases are the first reports of likely transmission of pathogens by FMT involving stool that came from OpenBiome, which has shipped more than 50,000 FMT treatments to physicians since 2013.

The patients who developed the infections received FMT product prepared from three OpenBiome donors. The two patients who developed EPEC infections were treated with stool from two donors, and the six STEC patients received stool from one donor. OpenBiome says all unused material from the donors has been destroyed.

The FDA says bacterial isolates from the patients’ stools are not yet available to determine if the STEC or EPEC organisms are genetically identical to the organisms from the stool donors—a finding that would confirm that the donor stool was the source of the infection.

In response to the safety alert, OpenBiome says it is immediately implementing changes to its screening program in collaboration with the FDA.

While the company has previously screened donor samples for STEC via enzyme immunoassay, and says the donor involved in the STEC cases tested negative at all screens, OpenBiome will add polymerase chain reaction (PCR) testing for STEC to its screening process. PCR tests on retained donor samples conducted after Openbiome was notified of the infections were found to be positive for STEC.

The retained stool samples from the donors linked to the EPEC infections were found to be positive for EPEC upon further testing from OpenBiome. The company says it has not previously screened donors for EPEC, a position based on international and national guidelines, but will immediately implement EPEC screening by PCR into its donor screening protocol.

“In addition to updating and implementing STEC and EPEC screening into our quality and safety protocols, OpenBiome is also working with FDA to implement retrospective screening of units to ensure that available material meets these new standards,” the company said.

After reporting the infections to the FDA, OpenBiome received information that two additional FMT recipients who received stool from the donor linked to the STEC infections had died. The company said in an update today that the treating clinician for one of the patients determined that the patient had died from underlying cardiac causes, and testing for STEC was not performed. In the second case, testing of donor material was negative for STEC.

“Therefore, it was determined that the death was unrelated to STEC,” the company said.

FMT safety issues

FMT has been found in several studies to be a highly effective treatment for recurrent C difficile infections that aren’t responding to antibiotics, and at least 10,000 FMT procedures for recurrent C difficile are performed each year. FMT is also being investigated for treating other conditions in more than 300 trials.

The idea behind the procedure is to introduce healthy bacteria from a donor into the gut microbiome of a sick recipient and restore the balance between good and bad bacteria.

But this is the second safety alert issued by the FDA regarding FMT. In June 2019, the agency warned of the potential for dangerous infections after two FMT patients developed drug-resistant bloodstream infections and one died, and the agency halted a number of FMT trials until additional screening measures could be put in place. A subsequent paper in the New England Journal of Medicine revealed that the two patients, both of whom were enrolled in clinical trials at Massachusetts General Hospital in Boston, had extended-spectrum beta-lacatamase (ESBL)-producing E coli in their blood.

The two patients had both received stool from Mass General that came from the same donor. While the hospital had screened the stool for C difficile and the presence of drug-resistant pathogens by the hospital, it had not screened it for ESBL-producing E coli. The authors of the paper could not conclusively attribute the infections to FMT, but suspected the patients likely acquired the pathogen from the procedure.

RESOURCE:  http://www.cidrap.umn.edu/news-perspective/2020/03/fda-warns-about-infections-linked-fecal-microbiota-transplants?utm_source=dlvr.it&utm_medium

 

 

Panic Buying Places Stress On Communities, Patients, and Families Especially Those Living With Multiple Gastrointestinal Diagnosis

Over the past few weeks there’s been a run on  toilet tissue, facial tissues, instant hand sanitizers, paper towels, bleach and cleaning products, and bottled isopropyl alcohol.

The media has recommended residents in all communities to be prepared and to have at least two-weeks of canned foods, cleaning supplies, and personal items on hand in the event a Coronavirus COVID-19 quarantine situation should arise.

We can all appreciate being prepared for unexpected circumstances, however; please base your purchases to your family needs and based on the suggested time being publicized and provided by the media.

There have been reports of families purchasing twenty cases (bulk amounts) of toilet tissue and clearing off the shelves at local stores of instant hand sanitizers.  This type of buying is creating supply shortages, empty shelves, zero inventory, and undue stress to patients and families in communities living with chronic illnesses including gastrointestinal symptoms and diagnosis.  Patients diagnosed with C. difficile infections are being left without necessary household items due to the extreme purchases occurring in some communities.

It is OK to stock in but not hoard products should a quarantine become necessary.

The Centers for Disease Control and Prevention has required some U.S. citizens who returned from China to be quarantined for 14 days. But local communities may have reason to respond to “severe” disruptions as the situation evolves, as the CDC said last week.

That has led many Americans to begin preparing for an extended stay at home, whether it’s encouraged by local officials or it’s a personal decision. Experts are warning against panic buying and hoarding of products such as toilet paper, water and cleaning supplies.

A useful article published in USA Today – How To Prepare For a Coronavirus  –  COVID-19

https://www.usatoday.com/in-depth/money/2020/03/04/coronavirus-what-stock-up-and-how-prepare-your-emergency-kit/4937518002/