Tag Archives: C. diff. for healthcare

A World of Thanks To the C Diff Foundation Volunteer Patient Advocates Around the Globe

National Volunteers Week     #NVW2016

 

Did you know that it is  NATIONAL VOLUNTEER WEEK
April 10-16, 2016

President Richard Nixon established National Volunteer Week with an executive order in 1974, as a way to recognize and celebrate the efforts of volunteers. Every sitting U.S. president since Nixon has issued a proclamation during National Volunteer Week (as have many U.S. mayors and governors).  Since then, the original emphasis on celebration has widened; the week has become a nationwide effort to urge people to get out and volunteer in their communities.

To each C Diff Foundation Volunteer Patient Advocate, , on behalf of all the staff and the thousands of members around the globe we want to say THANK YOU!

Your continued support and efforts contribute in a significant way to our mission of educating, and advocating for C. diff. infection prevention, treatments, and environmental safety awareness worldwide.

November marked our third  year in “Raising C. diff. infection Awareness” campaign and we thank the many organizations who supported and contributed by sharing information with others.  We are all working toward a shared goal in witnessing a reduction of newly diagnosed C. diff. cases and “None of us can do this alone…..all of us can do this TOGETHER!”

We celebrate our volunteers and this week stands as a reminder that our daily work sharing information, educating, and advocating for C. diff. infections, remains not only critical but it is urgent.

We do not know when new interventions to prevent, to treat, and protect our environments with products that will  eradicate C. diff. spores will become available to the public.  The good news is that we do know that there are many positive interventions presently in clinical trials, which give us all HOPE.

Visit the website for updates and feel free to inquire if you or a loved one would be considered a candidate to participate in an ongoing clinical trial:

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

This is why acts of sharing the C Diff Foundation literature during every opportunity quickly opens doors of knowledge helping others learn how to prevent acquiring this painful and life-threatening infection, treatments available, and disinfecting products with EPA Registered C. diff. kill for environmental safety–  to  help save lives.

Reminder that there is always information and support  available and  only a phone call away 1-844-FOR-CDIF

The C Diff Foundation Volunteer Patient Advocates build awareness, help build support and provide education of C. difficile infection prevention, treatments, and environmental safety measures  to patients, survivors  their families and community healthcare professional centers/offices.  They also  guide individuals in giving a voice to patients, survivors and their families on healthcare-related infections, informing the public,  health-care providers (hospitals, healthcare professionals, etc.), organizations of health-care professionals, the educational world, with the medical, Governmental agencies, and pharmaceutical research communities.

We provide our Volunteer Patient Advocates with the necessary tools, and updates to generate positive results.

Do you have a few extra minutes to share vital information with others to raise C diff. infection awareness in your community?

By becoming a C Diff Foundation Volunteer Patient Advocate you will make a BIG difference and help spare others the pain, suffering, and tragedy of loosing a loved one that is caused by a C. diff. infection.

Contact our office for additional information and register today by e-mailing the C Diff Foundation your name and a valid mailing address to receive an official  C Diff Foundation Volunteer Patient Advocate Packet

info@cdifffoundation.org

On this day, and throughout the year ahead, we want you to be confident that your Volunteer Membership in the Foundation is bringing important information out into the communities and throughout the world through the educational brochures, cards, letters, and from sharing your own personal experiences with others.  Please be sure to share your journey with others in need of “HOPE” on the C. diff. Survivors Alliance Network website  http://www.cdiffsurvivors.org

Your continued donations received during the year are always appreciated. Your gifts assist the Foundation in promoting C. diff. infection prevention, treatments, and environmental safety education, and advocacy to healthcare professionals, families, patients, and communities world-wide.  We are grateful for your assistance, dedication, and support and we hope the Foundation has also been helpful to you.  If you have any suggestions about how we can serve others better or share the information more effectively, please let us know.  You are welcome to email, telephone, or write to the Foundation at any time.

We certainly look forward to your continued Volunteer Membership in the Foundation.  There is so much more that needs to be accomplished and we continue to move forward together promoting our mission, which is entirely dedicated for the good of others.

May you and your families experience continued HOPE for good health, happiness, and peace throughout the year.

Thank You for helping prevent further pain and suffering worldwide by sharing in the

C Diff Foundation’s mission today.

 

Fecal Transplants (FMT) Treating Clostridium difficile Infections; U.S. Food and Drug Administration (FDA) Seeks Comment on What Investigational New Drug (IND) Requirements To Waive

Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive

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The US Food and Drug Administration (FDA) on Monday February 29, 2016,announced new draft guidance that aims to further assure that patients infected with the bacterium Clostridium difficile and not responding to standard therapies can access poop transplants, also known as fecal microbiota for transplantation (FMT).

FDA considers FMT an investigational new drug (IND), which requires physicians and scientists to file an IND application if they intend to use the treatment for clinical practice or research.

However, FDA has issued guidance stating that FMT may be used to treat 

C. difficile infection not responsive to standard therapies outside of a clinical trial. 

New Guidance

The latest draft guidance offers new notice that FDA intends to exercise enforcement discretion regarding the IND requirements for the use of FMT to treat C. difficile infection.

As far as what FDA wants to discuss on this new draft guidance, the agency says it’s requesting comments on which IND requirements are appropriate to waive.

In particular, FDA is requesting comments on the requirement for institutional review board review of the use of FMT to treat patients with C. difficile infection not responding to standard therapies when the FMT is provided by a stool bank,” FDA says.

Background

The draft guidance comes as over the past few years, FMT, which basically involves the transfer of a healthy donor stool to the bowel of a patient infected with C. difficile, has emerged as an effective means to treat recurrent forms of the bacterial infections, according to a study in the Journal of Law and Biosciences.

Rachel Sachs, an academic fellow at Harvard University’s Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, and an author of that study, explained to Focus that previously FDA said it would regulate FMT like a biologic, but that the decentralized, hospital-based model of FMT envisioned in this new draft guidance more closely resembles the agency’s models for regulating tissue or cord blood products.

Two companies – Rebiotix and Seres Therapeutics – have been granted orphan drug designations for their INDs as FMT treatments for recurrent C. difficile infections, which affect between 85,000 and 110,000 people in the US annually.

And Sachs said she’s under the assumption that once a company gets FDA approval for their FMT product, FDA will revoke its enforcement discretion included in this new guidance.

Guidance Details

FDA said Monday it intends to use this discretion for waiving certain IND requirements, provided that:

  • The licensed health care provider treating the patient obtains consent from the patient or his or her legally authorized representative for the use of FMT products. The consent should include, at a minimum, a statement that the use of FMT products to treat C. difficile is investigational and a discussion of its reasonably foreseeable risks;
  • The FMT product is not obtained from a stool bank; and
  • The stool donor and stool are qualified by screening and testing performed under the direction of the licensed health care provider for the purpose of providing the FMT product for treatment of the patient.

And FDA makes clear that an establishment that collects or prepares FMT products “solely under the direction of licensed health care providers for the purpose of treating their patients (e.g., a hospital laboratory) is not considered to be a stool bank under this guidance.”

Sachs co-authored her article with Carolyn Edelstein, director of policy and global partnerships at OpenBiome, a nonprofit stool bank that sells FMT capsules (recommended dose of 30 capsules plus a safety test capsule costs $535, or stool preparations for delivery by colonoscopy, enema, and EGD/naso-enteric tube are $385 each) after conducting first-in-human evaluations (N=4) and a randomized dose-finding study (N=17).

Edelstein told Focus that the draft “suggests that the FDA is seeking to set up a more tailored regulatory scheme, one that considers stool banking separately from small-scale directed donation. We are in favor of seeing stool banking receive more regulatory oversight. We plan to answer the agency’s request for comments on the elements of a regulatory framework that would lend this oversight to the practice of stool banking without unduly burdening the physicians and healthcare facilities using banked material, and by extension, unduly limiting access to the treatment for their patients.”

FDA also explains that there were “difficulties in interpretation” with previous draft guidance, particularly around the provision that the donor be known either to the patient or to the treating licensed health care provider, noting “the revised approach more accurately reflects our intent to mitigate risk, based on the number of patients exposed to a particular donor or manufacturing practice rather than the risk inherent from any one donor.”

But as new FMTs are likely to hit the market as orphan drugs, the bigger issue at play could be associated with cost. Sachs noted that any FDA-approved treatment, particularly since it’s an orphan product, could be expensive (upwards of thousands of dollars for treatment).

 

Source:

http://www.raps.org/Regulatory-Focus/News/2016/02/29/24428/Fecal-Transplants-to-Treat-C-difficile-FDA-Seeks-Comment-on-What-IND-Requirements-to-Waive/

Asymptomatic carriers of toxigenic C. difficile in long-term care

Asymptomatic carriers of toxigenic C. difficile in long-term care facilities: a meta-analysis of prevalence and risk factors.

Abstract

BACKGROUND:

The impact of Clostridium difficile colonization in C. difficile infection (CDI) is inadequately explored. As a result, asymptomatic carriage is not considered in the development of infection control policies and the burden of carrier state in long-term care facilities (LTCFs) is unknown.

PURPOSE:

To explore the epidemiology of C. difficile colonization in LTCFs, identify predisposing factors and describe its impact on healthcare management.

DATA SOURCES:

PubMed, Embase and Web of Science (up to June 2014) without language restriction, complemented by reference lists of eligible studies.

STUDY SELECTION:

All studies providing extractable data on the prevalence of toxigenic C. difficile colonization among asymptomatic residents in LTCFs.

DATA EXTRACTION:

Two authors extracted data independently.

STATISTICAL METHODS:

The pooled colonization estimates were calculated using the double arcsine methodology and reported along with their 95% random-effects confidence intervals (CIs), using DerSimonian-Laird weights. We assessed the impact of patient-level covariates on the risk of colonization and effects were reported as odds ratios (OR, 95% CI). We used the colonization estimates to simulate the effective reproduction number R through a Monte Carlo technique.

RESULTS:

Based on data from 9 eligible studies that met the specified criteria and included 1,371 subjects, we found that 14.8% (95%CI 7.6%-24.0%) of LTCF residents are asymptomatic carriers of toxigenic C. difficile. Colonization estimates were significantly higher in facilities with prior CDI outbreak (30.1% vs. 6.5%, p = 0.01). Patient history of CDI (OR 6.07; 95% CI 2.06-17.88; effect derived from 3 studies), prior hospitalization (OR 2.11; 95% CI 1.08-4.13; derived from 3 studies) and antimicrobial use within previous 3 months (OR 3.68; 95% CI 2.04-6.62; derived from 4 studies) were associated with colonization. The predicted colonization rate at admission was 8.9%.

CONCLUSION:

Asymptomatic carriage of toxigenic C. difficile represents a significant burden in LTCFs and is associated with prior CDI outbreaks in the facility, a history of CDI, prior hospitalization and antimicrobial use. These findings can impact infection control measures at LTCFs.

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

http://www.ncbi.nlm.nih.gov/pubmed/25707002