Tag Archives: C Diff Foundation

C. diff. (CDI) Treatment and Prevention Options Through Clinical Trials

Posted in C. diff. Treatment Options, C. difficile Treatment Clinical Studies, C.diff. clinical trials by

Every scientific research and development, every clinical trial in progress is a glimmer of hope………..HOPE for clinically safe and approved avenues to prevent and treat a C. difficile infection.

Listed below you will find a few examples of  organizations who have active
C. difficile Prevention and Treatment clinical trials in progress.  Click on each organization’s website listed to review their clinical trial study opportunities and inquire if you or your loved one qualify to participate in their study. 

 

To Learn More About Clinical Trials —

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Learn more About Clinical Studies and About This Site, including relevant History, Policies, and Laws.  Click on the link below to be redirected to the clinicaltrials.gov website: https://clinicaltrials.gov/

Clinical Studies Are In Progress To

Help Them — Help You — Help Others  ♥

Here is a partial-listing and explanations of Clinical Trial Phases:

Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question.

  • Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
  • Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
  • Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

THE FOLLOWING ARE A FEW EXAMPLES OF CLINICAL TRIALS AVAILABLE ADDRESSING C.difficile INFECTION PREVENTION AND TREATMENTS. 

Visit clinicaltrials.gov for a full listing.

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  C. diff. Infection (CDI)_Prevention Clinical Studies

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DAV-Logo (2)

Da Volterra is a is a clinical stage biotechnology company whose vision is to be a trusted and acknowledged leader in the microbiota field. Our mission is to discover, develop and bring to market safe and novel therapeutic options, preserving patients’ microbiota to prevent and cure life-threatening diseases. Our most advanced product is DAV132, an oral product to be co-administered with any antibiotics, in order to protect patients from antibiotic-induced intestinal microbiota disruption. DAV132 decreases the risk of triggering Clostridium difficile infection by inactivating residual antibiotics in the colon
before they can disrupt the bacterial flora, without impacting the systemic efficacy of the antibiotics.

It is noteworthy that DAV132 is developed to accompany all oral and intravenous antibiotics of any class and would therefore significantly reduce the risks to acquire C.difficile infections for patients at risk. We see DAV132 as a real game changer for C.difficile prevention.

Have a look at DAV132 webpage and video presenting its mechanism of action: https://davolterra.com
The video is highly illustrative of what C.diff is and how C.diff is triggered.

We have already performed 4 clinical trials with DAV132 in healthy volunteers and we have a very exciting dataset (both preclinical and clinical) suggesting that DAV132 will very effectively prevent C.diff infections. We are currently conducting a clinical trial, in patients actually treated with antibiotics and at-risk of C.diff.             

Information on this study is available here: https://clinicaltrials.gov/ct2/show/NCT03710694

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Pfizer, a leader in vaccine research and innovation, continues to advance its Clostridium difficile (C. difficile) vaccine candidate, PF-06425090. The Phase 3 trial CLOstridium difficile Vaccine Efficacy TRial (CLOVER), is an ongoing placebo-controlled trial designed to assess whether PF-06425090 prevents the disease, and whether it is safe and well-tolerated in adults 50 years of age and older. [i], [ii]

Additional information about CLOVER can be found at CloverTrial.com.

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Seres Therapeutics

“Is another C. diff.  infection getting in the way of your life?”

Seres Therapeutics is developing Ecobiotic® drugs designed to prevent C diff infections from coming back again.

Most C diff infections occur after antibiotic treatment. Why? Our gut contains trillions of microbes, called the microbiome, which protects us from bacterial invaders that can cause disease. Antibiotics kill both good and bad bacteria, leaving holes in this ecology (community) of microbes. When the microbiome is damaged, bad bacteria, like C diff, can take advantage and cause disease. Although specific antibiotics can kill the active C diff bacteria, the sleeping forms (ie, spores) are untouched. These spores turn into active C diff bacteria and cause disease again and again – usually after antibiotic treatment has finished.

Seres Therapeutics has developed an oral medicine called SER-109, which aims to prevent C diff from coming back by repairing the microbiome. This Ecobiotic® drug is being studied in a large Phase 3 clinical trial that is enrolling patients who have had multiple C diff infections. This important clinical study is being done in the United States and Canada and may provide the final clinical data needed to support FDA and Canadian drug approvals.

To learn more about Seres Therapeutics and Clinical Trials In Progress please click on the following link to be redirected:

www.serestherapeutics.com

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Vedanta Biosciences, Inc. is a clinical-stage microbiome company developing a new category of therapies for immune-mediated diseases based on rationally-defined consortia of human microbiome-derived bacteria.

VE303 is a defined bacterial consortium designed to prevent recurrent C. difficile infections (“CDI”).  VE303 is a preparation of eight different bacteria that were selected for their presumed ability of preventing regrowth of C. Difficile.

Why bacterial consortia?

Unlike fecal transplants, which require use of donors’ stool and are an inherently variable procedure, bacterial consortia therapeutics are defined drug compositions produced from clonally isolated bacteria that can trigger targeted immune responses. And unlike reductionistic approaches such as single strain probiotics, they can robustly shift the gut ecosystem.

The results of the Phase 1 study of VE303 showed both rapid expansion of protective VE303 bacteria in the gut and accelerated recovery to a healthy microbiome after disruption to the normal microbiome in the gut caused by antibiotics.  Based on these Phase 1 results, Vedanta is now evaluating VE303 (the “CONSORTIUM” study) in individuals with CDI to see if it can prevent future CDI recurrences by restoring the intestinal bacteria to a healthy state.

About

CONSORTIUM (NCT03788434) is a randomized, double-blind placebo-controlled Phase 2 study to evaluate safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) and efficacy of VE303 in patients with a recent diagnosis of CDI, who have completed a course of antibiotics but remain at risk for recurrence. The primary endpoint will be prevention of infection recurrence at eight weeks.

CONSORTIUM is currently enrolling participants across North America (U.S. and Canada) who have been diagnosed with high-risk CDI.

For additional study information or to locate a study site near you, please visit Clinicaltrials.gov:

https://www.clinicaltrials.gov/ct2/show/NCT03788434

If you have questions about the study or are interested in study participation, please email:

Consortium02-ctinquiries@vedantabio.com

 

Please take a moment to view a brief presentation, created by Vedanta Biosciences, to learn more about
C. difficile infections, treatments, and clinical trials
https://f.io/oRC8HkFV

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Valneva Clinical Trial of its Clostridium difficile vaccine candidate

UPDATE:  February 2019

Valneva’s Clostridium difficile vaccine candidate – VLA84

Valneva successfully completed Phase 2 development of its prophylactic vaccine candidate against Clostridium difficile infection, confirming previously announced positive topline data. The vaccine candidate VLA84 is Phase 3 ready.

Valneva seeks to partner its Clostridium difficile vaccine candidate. At this point, however, potential partners are hesitant about the level of investment required to fund a Phase 3 clinical trial. Therefore, the Company reviewed its development and partnering approach. Valneva will consider using the first CDI vaccine approval and to conduct a head to head, non-inferiority Phase 3 trial, based on an immunological correlate that is expected to substantially improve the investment – risk profile of an in-house, or partnered, development to market.

The Company estimates that the total market potential for prophylactic C. difficile products may exceed $1 billion annually.

 

BACKGROUND:    Lyon (France), December 18, 2014 – European biotechnology company Valneva SE (“Valneva”) announced today the initiation of the Phase II clinical trial of its VLA84 prophylactic vaccine candidate against Clostridium difficile (C. difficile), the main cause of nosocomial diarrhea. Data from the Phase I study in healthy elderly and adults showed good safety and immunogenicity of the vaccine candidate, and indicated functionality of induced antibodies, supporting the Company`s decision to progress the vaccine
candidate into Phase II

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C. diff. Infection (CDI) Treatments

Clinical Studies

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Acurx Pharmaceuticals, LLC  a privately held, clinical-stage, a biopharmaceutical company developing new antibiotics for difficult-to-treat bacterial infections, announced that its lead product candidate, ACX-362E, has successfully completed the 68-subject, double-blind, placebo-controlled, multiple-ascending dose Phase 1 clinical trial of ACX-362E in healthy volunteers.  The Phase 1 clinical trial was first-in-man for a new class of antibiotics that work by inhibiting DNA synthesis in certain bacterial cells (pol IIIC inhibitors).  Pol IIIC is required for DNA replication of many Gram-positive pathogens, including  Clostridioides as well as Enterococcus, Staphylococcus, and Streptococcus.  Multiple-dose levels up to 450 mg BID for 10 days were shown to be well tolerated. Any adverse events attributed to ACX-362E were mild, transitory, and did not interrupt treatment in any subject. Blood levels of ACX-362E show low systemic exposure,  indicating poor oral absorption and desirable in treating CDI.  Additionally, fecal concentrations of ACX-362E at higher dose levels rapidly exceeded the concentrations known to inhibit C. difficile by several hundred-fold and were sustained for the duration of the 10-day treatment period.

ACX-362E is a novel, oral antibacterial agent for the treatment of Clostridioides difficile infection (CDI), an acute, serious, potentially life-threatening, intestinal infection. This Phase 1 study included a 6-subject vancomycin treatment arm (the current standard of care for CDI) for comparative microbiome analysis by Dr. Kevin Garey, Professor, University of Houston College of Pharmacy and Principal Investigator for this aspect of the trial.  ACX-362E effects on the fecal microbiome were compared to those produced by vancomycin over the 10-day treatment course. The results demonstrate that while vancomycin significantly disrupts Bacteroidetes and Firmicutes, deemed to constitute more than 80% of the favorable microbiota in the gastrointestinal tract, ACX-362E had minimal impact on the Bacteroidetes and Firmicutes.  Specifically, vancomycin treatment resulted in a 3-4 log reduction in Bacteroides while ACX-362E doses of 300 or 450 mg BID showed minimal effect.

About the Phase 1 Clinical Trial
The Phase 1 trial was a double-blind, placebo-controlled study to determine safety, tolerability, pharmacokinetics and fecal concentrations of ACX-362E in healthy volunteers conducted in the U.S.  A total of 68 subjects, of which 44 were given active drug, were enrolled in 3 parts: Part 1, Single-ascending dose (n = 32); 6 active/2 placebo per dose cohorts of 150, 300, 600, and 900 mg; Part 2: Food-effect crossover at 300 mg (n = 8); Part 3: Multiple-ascending dose (n = 22); 6 active/2 placebo per dose cohort; BID dosing x10 days; 30-day follow-up visit for microbiome sampling; dose cohorts of 300 and 450 mg.  Additionally, it included an “Active” control group for microbiome studies, oral vancomycin q6H x10 days (n = 6)

Safety information was analyzed through assessment of adverse events and other standard safety measures, while concentrations of ACX-362E were determined in both the blood and the feces, the latter being the critical site of drug delivery for treating CDI.  In addition, Acurx partnered with Dr. Kevin Garey’s laboratory at the University of Houston to perform state-of-the-art microbiome testing of gastrointestinal flora in trial subjects.

.For more information, please visit our website at wwwacurxpharma.com.

View original content:http://www.prnewswire.com/news-releases/acurx-successfully-completes-ph1-clinical-trial-for-acx-362e-in-cdi-300908613.html

SOURCE Acurx Pharmaceuticals, LLC  Released August 28, 2019 / January 2020

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  • Having reached a sufficient number of clinical centers, Phase II clinical trial testing the antibiotic candidate DNV3837 in Clostridioides[1] (Clostridium) difficile infections will start this summer in the United States and Germany 
  • This trial will be conducted as part of an active Investigational New Drug (IND) authorization and a recently updated version of the clinical protocol
  • The production of the first commercial batch of DNV3837 has been successfully initiated

DEINOVE (Euronext Growth Paris: ALDEI), a French biotech company that uses a disruptive approach to develop innovative antibiotics and bio-based active ingredients for cosmetics and nutrition, announced that all the conditions are in place for the upcoming start of the Phase II trial testing the antibiotic candidate DNV3837 for the treatment of Clostridioides difficile infections.

DNV3837 is a first-in-class antibiotic candidate targeting the treatment of Clostridioides difficile infections (CDIs), a disease classified as a priority by the WHO and one of the global leading causes of healthcare-related infections[2]. DNV3837 has demonstrated a promising efficacy profile, an acceptable tolerance in Phase I trials. It has obtained a QIDP designation and a Fast Track status[

DNV3837 will now enter Phase II trial for the treatment of CDIs. The clinical protocol has recently been adjusted and allows the trial to be conducted under the IND initially granted for the compound.

This multicentric open-label trial will be conducted both in Germany and the United States. Under the updated protocol, the number of sites, necessary for the implementation of its Phase II, has been reached. The inclusion of the first patient is planned for mid-2019. Medpace (Nasdaq: MEDP) was chosen as the Clinical Research Organization to oversee the trial.

In parallel, DEINOVE has started the production of the first DNV3837 batch on a commercial scale, in accordance with good manufacturing practices. This batch will be used in order to prepare enough material for conducting Phase III trial. CMC (Chemistry, Manufacturing, and Controls) operations in the United States have been contracted to a recognized CMO and the first production steps have been successfully completed in accordance with the agreed specifications.

For more information:  http://www.deinove.com/en

 

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Study: Bezlotoxumab Versus Placebo in Children With Clostridium difficile Infection (CDI) (MODIFY III)

Recruitment Status: Recruiting

The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab in children aged 1 to <18 years with a confirmed diagnosis of CDI who are receiving antibacterial drug treatment for this infection. (Source = ClinicalTrials.gov)

Click here to learn more about this study

Click here to see if there’s a site near you

 For Additional Site and Study Information:

Toll-Free: 1-888-577-8839

Email: Trialsites@merck.com

 ZINPLAVA™ (bezlotoxumab):

ZINPLAVA is a prescription medicine used to help decrease the risk of C-diff from coming back in people 18 years of age or older who are taking an antibiotic for C-diff and who have a high risk of C-diff coming back. C-diff is a bacterial infection that can damage your colon and cause stomach pain and severe diarrhea.

When people get C-diff, they often take an antibiotic to get rid of the infection. Even when treated by an antibiotic, C-diff can come back within weeks to months. ZINPLAVA helps to decrease the risk of the infection from coming back. It works when given along with the antibiotic that you are taking to treat C-diff. (Source = zinplava.com)

Click here to learn more about ZINPLAVA (bezlotoxumab)

 Study Sponsor: Merck

 

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Rebiotix Inc. is a clinical-stage biotechnology company founded to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome. Microbiota Restoration Therapy (MRT) is the company’s platform for delivering live microbes into a sick patient’s intestinal tract to treat disease.

Study:

The PUNCH CD3-OLS study is a Phase 3 clinical study to assess the safety and tolerability of Rebiotix RBX2660 for the prevention of recurrent Clostridium difficile infection (CDI) in a recurrent CDI population that is broader and more inclusive than that included in prior studies using RBX2660.

This open-label study is expected to enroll up to 200 patients at 80 research sites in the U.S. and Canada. Patients that meet the study requirements and choose to enroll will receive RBX2660, an investigational new drug (no placebo). Study patients whose CDI returns within 8 weeks after study treatment may be scheduled to receive an additional RBX2660 treatment. The study’s primary objective is to assess safety and tolerability of RBX2660 through 6 months after the final RBX2660 study treatment.

Additional information can be found  on the Clinicaltrials.gov website  https://clinicaltrials.gov/ct2/show/NCT03931941

Or through the Rebiotix website: https://www.rebiotix.com/

Rebiotix Inc., part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix has a diverse pipeline of investigational drug products built on its pioneering microbiota-based MRT™ drug platform. The MRT platform is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad consortium of live microbes into a patient’s intestinal tract. The lead drug candidate, RBX2660, is currently in Phase 3 clinical development for the prevention of recurrent Clostridium difficile(C. diff) infection. RBX2660 has been granted Fast Track status, Orphan Drug and Breakthrough Therapy designation from the US FDA for its potential to prevent recurrent C. diff infection. Rebiotix’s clinical pipeline also features RBX7455, a lyophilized, non-frozen, oral capsule part of a recently completed investigator-sponsored Phase 1 trial for the prevention of recurrent C. diff infection. For more information on Rebiotix and its pipeline of human microbiome-directed therapies for diverse disease states, visit www.rebiotix.com.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, women’s health, urology, gastroenterology, endocrinology, oncology, and orthopaedics. For more information,  visit www.FerringUSA.com.

 

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Summit Therapeutics  Ridinilazole is being developed by Summit Therapeutics as a potential treatment for
C. difficile infection (CDI). It’s a new antibiotic, and Summit is testing whether it can improve patient outcomes over the current standard of care, vancomycin, in two global clinical trials. In an earlier clinical trial in patients with CDI, ridinilazole was found to be superior to vancomycin in a measure called sustained clinical response, which tested if patients were cured after treatment and did not experience a recurrence within 30-days post-treatment. More information on ridinilazole can be found by visiting www.summitplc.com

Some key information about the trials:

  • Each trial is expected to enroll up to 680 patients
  • Patients will be randomized to receive either ridinilazole or vancomycin, and neither the patients nor the study doctors will know which drug they receive
  • Participation will involve about 7 study visits over approximately 100 days to track the safety and effectiveness of each drug
  • Patients who participate may be reimbursed for travel expenses associated with study site visits
  • Patients must be 18 years of age or older
  • Patients must have signs and symptoms of CDI, including diarrhea, in the 24 hours prior to entry in the trial and a positive toxin test on a stool sample produced within 72 hours of entry into the trial
  • Patients cannot have had more than one prior episode of CDI in the previous three months or more than three episodes in the past 12 months
  • Patients cannot have had more than 24 hours of CDI antibiotic treatment prior to entry into the trial
  • There are additional entry criteria and considerations; the study doctors will ultimately decide whether a patient is eligible for entry into the clinical trials and the patient will be required to give consent

Further details of the global clinical trials can be found by visiting: https://clinicaltrials.gov/ct2/show/NCT03595566 and https://clinicaltrials.gov/ct2/show/NCT03595553, and/or by speaking with one of the clinical trial sites.

The clinical trials will be taking place at sites in the US, Europe, Latin America, Australia and Asia. If you would like to be considered for enrollment into one of the clinical trials, please contact the study site nearest you.

ridinilazole has already received Qualified Infectious Disease Product, or QIDP, designation and has been granted Fast Track status from the US Food and Drug Administration

To learn more about ridinilazole and Summit Therapeutics, click on the following link

to be redirected to the Summit Therapeutics website:  https://www.summitplc.com/

Visit www.ricodify.com online resources for patients with CDI and their caregivers.  The website also includes a map of clinical sites, which is searchable by postcode.

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In October of 2017, Finch merged with Crestovo to form Finch Therapeutics Group.

The PRISM 3 clinical study is for patients who have had a recurrence of Clostridium difficile infection (CDI or C. diff). The study is evaluating the safety and effectiveness of the study drug (CP101) to prevent recurrence of CDI compared to a placebo. The study is currently enrolling across the United States.

This clinical trial (CP101) is in Phase 2.  For more information from
http://www.ClinicalTrials.gov  click on the following link:

https://www.clinicaltrials.gov/ct2/show/NCT03110133?term=PRISM+3&rank=3

The study drug, CP101, is a Full-Spectrum Microbiota™ investigational drug designed to deliver bacteria to the intestine. This bacteria may help overtake the surplus of C. diff. bacteria that cause CDI.

CP101 is encapsulated for oral administration. The powder is intended to be released from the capsules in the right part of your intestine where the bacteria may repopulate. This may aid in restoring the diverse community of bacteria found in the healthy human gut, which may prevent recurrence of C. diff..

Click here to learn more about PRISM 3 (https://www.prism3trial.com/trial) and see if there is a study near you and if you are eligible.

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CP101 drug products are in development and investigational at this time. No product has yet been approved by the U.S. Food and Drug Administration. Prolacta Bioscience is a company dedicated to Advancing the Science of Human Milk. It has been leading the way in developing human milk-based nutritional products for premature and other infants with special nutritional needs since 2005.

Prolacta has recently developed a potential therapeutic, consisting of beneficial components derived from human milk and is investigating its usefulness in the treatment of C. difficile associated diarrhea.  In a healthy individual, the bacteria population living in the gut (microbiome) provides many health benefits and can prevent pathogens from causing infections. Antibiotics wipe out the beneficial bacteria in the gut and can allow harmful bacteria such as C. difficile to overgrow.

C. difficile causes disease by producing toxins that injure the cells of the gut wall. Although some specific antibiotics can cure C. difficile infections, at times the pathogen can resist antibiotics by forming spores. These C. difficile spores are immune to the effects of antibiotics and, under certain conditions, can become harmful active bacteria, which start the disease cycle all over again. If the gut microbiome does not return to a healthy state, the C. difficile infection may still return after each antibiotic treatment.

Prolacta’s new product has natural biological activities that could help restore the individual’s healthy gut microbiome and support immune function in order to potentially reduce the risk of a relapse of C. difficile disease without having to introduce a new bacterial population collected from outside sources.

Some Key Information about the trial:
• Patients will be given liquid product (consisting of human milk-derived components) or placebo, administered orally three times daily for seven days
• Phase I Study
• Double-blind, randomized, placebo-controlled dose escalation trial
• Study subjects will receive one of three doses depending upon which dose group is recruiting at the time of their participation.
• Currently enrolling patients age 18 or older who have had no more than four prior occurrences of C. difficile associated diarrhea (CDAD) and are currently being treated with standard of care antibiotics.
• The target enrollment number is between 48 and 54.

The clinical trial will be taking place at the following locations in the US:
– Idaho Falls, ID Orlando, FL
– Butte, MT Miami-Dade, FL
– Omaha, NE Tampa, FL
– Ventura, CA New York, NY
For further information contact:  info@prolacta.com

case/control number C.diff. trial : NCT03793686

clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT03793686?term=Prolacta&rank=3

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2/2019 :  A PARTIAL LIST OF CLINICAL TRIALS UPCOMING

AND

CLINICAL TRIALS CURRENTLY ENROLLING —  FOR THE FULL LISTING VISIT clinicaltrials.gov

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C Diff Foundation and C diff Survivors Alliance Network Winter 2017 Bulletin

Posted in Announcements, C diff Nationwide Community Support Program, Holiday Notes by

 

Greetings from the main office of the C Diff Foundation and the C diff Survivors Alliance Network located in New Port Richey, Florida.  As we close 2017 we mark the 5th anniversary of the two organizations. We want to share with you a summary and reflection on this year’s events and campaigns moving our mission forward and message delivered worldwide. The mission and promoting C.diff. Awareness has been shared this year alone with over 81,453 listeners during Season III on C. diff. Spores and More Global Broadcasting Network (www.cdiffradio.com),  5,000+ visitors during global events, 9,600+ residents and business owners throughout villages and communities by our dedicated volunteer patient advocates, over 1,000 clinicians received up-to-date data expanding their knowledge during workshops and local symposiums offered worldwide, 3,000+ incoming national hot-line calls, with thousands of e-mails seeking information.

After each event, workshop, meeting — we thank the individuals for the five years of opportunity to provide the life-saving data educating and advocating for C. difficile infection prevention, treatments, environmental safety and support worldwide.  The mission of the C Diff Foundation is the momentum of charity that has proven effective and grown over the past five years.  A single act of charity grows into more and greater charity worldwide.  The work each member of the C Diff Foundation with the hundreds of Volunteer Patient Advocates, promote the Foundation’s mission which never stops with a single act.  Instead, it builds, it grows, and it expands into an exponential impact of good in the world helping to save lives.  We thank you for your continued support and encourage you to continue your journey, proposing three verbs important to the C Diff Foundation and the C diff Survivors Alliance Network in general.

The first of these verbs is “to promote” C.diff. Awareness. It is the first step that opens doors in educating individuals, clinicians, communities in learning more about this life-threatening infection which causes a great amount of pain and suffering around the globe.  It is essential and it is the compass in reaching shared goals.

The second verb is “to heighten awareness” across the nation to continue proclaiming November Clostridium difficile infection awareness month. The Governors proclaimed November C. difficile (C.diff) infection awareness month in 2017 and we encourage them “to welcome” this proclamation in 2018 with more than a yearly executive order of greeting or inviting their residents to take notice.  We look forward to working with delegates, with your support, to make this proclamation statement nationwide and welcome the importance of the time, education, programs, and agenda in place addressing this life-threatening infection.  The C Diff Foundation advocates and supports the individuals and families suffering during and after being treated for a C. diff. infection.

Finally, the third verb that the C Diff Foundation and C diff Survivors Alliance Network propose is “to go.”  Here we are all challenged to do something with the gifts we have been given and what we are able to do.  With the unity of members with volunteers with the patients, families, and clinicians we can make a difference with enthusiasm and simplicity to get up and go.  We can do for others what we could not do for ourselves during our illnesses, during the isolation, during the losses, during the pain and suffering.  As members of the C Diff Foundation we know that our enthusiasm  for our mission is the desire to bring awareness and
promote C. difficile infection prevention, treatments, environmental safety and support worldwide.  We witness the change by delivering the data and information within villages,  through major cities and  small communities — it is only by taking this path that we gain satisfaction knowing that the news is delivered with enthusiasm “to promote, to heighten awareness and to go” with the members and volunteers in the C Diff Foundation and C diff Survivors Alliance Network.

We are truly grateful for your continued dedication, efforts and support and thank you again for making this year’s November anniversary such a special occasion through the growth and advances made worldwide.   Let’s carry the mission into the New Year, carving new paths to witness the decline in newly diagnosed cases of Clostridium difficile (C.diff., C. difficile) infections and saving lives worldwide.

“None of us can do this alone ~ All of us can do this together.”

 

 

Clostridium difficile (C. diff.) Infection; A Patient’s Spouse Perspective Living Through a “C. Difficult” Nightmare

Posted in support, Survivor Experience by

HandsTouchingSun“Through better or worse, richer or poorer, through sickness and health — we survived not one but two separate C. diff. infections”  stated Angelo Ortiz, a C. diff. Survivor.

*the patient’s name has been purposely omitted for privacy.

C. difficult is an excellent term used to partially describe
the experience living through a Clostridium difficile infection with a partner,
a soul-mate, or a significant other.

A way of regarding this situation objectively ; a point of view shared with fellow C. diff. survivors also walking this path with their loved ones.

Interviewer:  Angelo, did you know what a Clostridium difficile infection was, also known as C. diff. ?

Angelo:  Yes, being in Nursing I have cared for patients diagnosed with C. diff. infections.  However; I did not surmise that my wife was suffering from this infection.  Usually patient’s bowel movements will have a significant obnoxious odor that can alert healthcare providers to surmise a C. diff. infection.  This is not always the case anymore.  Over the past decade healthcare professionals have noticed changes in symptoms, treatments, and the overall microbiology aspects of this infection.  The lack of odor in patients diagnosed with a C. diff. infection is one of them.

Interviewer  Had your wife been on Antibiotics or in a hospital being treated for an infection prior to being diagnosed?

Angelo:  No, she was not ill, had not been on antibiotics and not been a patient in a hospital.  Nevertheless; working in a hospital and being in close proximity with patients being treated for this infection may have played a big role in her acquiring it.

Interviewer:  Did the healthcare environmental operations utilize a EPA Registered product with a
C. diff. kill claim?

Angelo:  In 2009 Clorox Commercial Solutions Ultra Clorox Germicidal Bleach ® was named the first and only product to obtain Federal EPA registration for killing C. diff. spores on hard, non porous surfaces when used as directed.  Before then there weren’t any products available addressing
C. difficile spores and C. diff. spore elimination through disinfecting.  Since that time, we have come a long way and the available products EPA Registered addressing C. diff. and also UV Disinfecting systems available to healthcare facilities fighting major healthcare-associated infections.

Interviewer:  What were the symptoms your spouse was experiencing on a daily basis?

Angelo:   Where do I begin?  There was pain, so much pain that it made my heart break.  I cried when she cried and screamed.  Talk about feeling helpless.  Watching my beautiful wife lay curled up in a fetal position in a hospital bed that we had to rent and place in the living room because she was too weak to climb the stairs in our townhouse.  It wasn’t pain she would tell me, it was her intestines twisting and turning and we could hear the whooshing and active bowel sounds.  They were so loud and audible we didn’t need our stethoscopes to access them.  If a half of a sandwich was ingested, it was eliminated within 45 minutes.  Maintaining hydration was a challenge every single day.  The docs had my wife following a clear liquid diet and with each office visit she would tell each doctor assessing her, “I can’t eat, everything I eat just runs right through me.”  They would tell her to not worry about it, stay on the liquids, eat what you can.  There wasn’t a lot of nausea or vomiting, no fever, but there were times where she would shiver and complain of feeling cold.  Falling into malnutrition and also mal-absorbtion also  caused G.I. system complications later on, too.

Interviewer:   What healthcare providers were visited and rendered care?

Angelo:   It took six months of weekly visits complaining of the G.I. symptoms and pain, to receive a concrete diagnosis by the Primary Care Physician.   After three months, after being diagnosed with a CDI and after the algorithm of treatments were not making a difference, the referral to be assessed by a Gastroenterologist came about.   During the next six months my wife was seen by all fourteen Gastroenterologist’s in the one practice without any significant improvements noted under their care.  After the six month of weekly visits and continued changes in medications, the physicians recommended a referral to Hospice.

Interviewer:   Where did the next level of care take you?

Angelo:   A Physician studying Clostridium difficile, suggested getting a second opinion by a Gastroenterologist at Duke University Hospital in N.C..   I met with the benefits coordinator at work who assisted in the process to obtain the approval for the second opinion.   Just to let everyone know, always call the customer service phone number on the back of the ID card and speak to the Case Manager working on the care in progress to learn of “how to” obtain a second opinion or visit the benefits coordinator at work to learn more about this option.  It is good information to know and if it weren’t for the one Physician suggesting this option to us I wouldn’t have a wife to talk about today.

Interviewer:   What was done differently at the new Physician’s office at Duke?

Angelo:   This visit bought my wife her fourth Colonoscopy and Endoscopy, however; we didn’t fight it.  If it was going to help the physician diagnose and treat this infection, we’re all in.   The results were on the positive side, no noted new changes or new diagnosis and another negative Celiac/biopsy was done via: endoscopy.  The Physician made a decision to utilize a medication being clinical studied for C. difficile that was already FDA approved for a different gastrointestinal diagnosis.  The cost of the medication was, as they would show on a menu, $$$$$.  We were extremely happy that this physician had the medication samples available.   Ten days of taking the medication prescribed there were noticeable changes taking place.  There was less bloating, less cramping, a lot less pain, the explosive – watery stools that were >15 x’s in a day were decreasing.  We had not witnessed any positive changes in almost a year.
This was a down right miracle in our book.

Interviewer:   You mentioned the medication expense.  Did you encounter other financial expenses during this infection?

Angelo:   Financial Expenses?   We drained our savings first after my wife was forced to resign from her job.  You can’t work in Nursing when you are tied to the bathroom, they don’t go together really in any job.  You just can’t work and shouldn’t work if you are being treated for an active CDI because it is a contagious infection.  That is why in the hospitals and healthcare facilities isolation precautions are implemented to help stop the spread of the infection.  So we go from being a two income family to a one income family over night.  Is anyone really prepared for that kind of a financial change over night?  The 401K was utilized to cover healthcare costs, prescriptions, co-pays, emergency room fees, specialists, travel, outpatient diagnostics, and the monthly hospital bed rental.  The mortgage was based on our income — joint, the vehicles were purchased separately, there weren’t many monthly recurring bills — it was all of the new bills being created by this illness.   Now we’re faced with the medical bills, and how do we pay for the living expenses all on one salary coming in?  You do what you have to do, we drained all of the retirement funds and the golden nest egg was scrambled.

Interviewer:   How long did it take your wife to get back on her feet and back to work?

Angelo:   It took her almost two years to feel strong enough to re-enter the work force.  From being ill so long and bed ridden from exhaustion, there was physical therapy, there was working with two Registered Dietitians from the hospital to retrain the gut after being on a clear liquid diet for over a year.  There were weekly visits to specialists who were monitor all the systems that were affected by the negative impact of this infection.  Hematologist, Gastroenterologist, Cardiologist, Endocrinologist, and P.T., and so much more.

Interviewer:   Do you have any message that you would like to share with others who are the  spouse/partner/significant other with another diagnosed with a C. diff. Infection?

Angelo:   Sure.   Don’t give up!  There were so many days that were darker than nights and we didn’t think there would ever be a light at the end of the tunnel.  It’s through our faith, our hope, and support of friends who weren’t afraid to visit us, along with reaching out to dedicated professionals and the Foundation’s that work with these professionals that care and know how to maneuver through the thorn bushes that brought us forward and through this nightmare.  We’ll always be dedicated and supportive to the C. diff. community and the C Diff Foundation and their members for their continued help.

 

We thank Angelo for his time and for sharing this journey through a C. diff. infection with a spouse, partner, soul-mate, or significant other.

 

To hear more about C. difficile infection prevention, treatments, clinical studies, environmental safety products and home care —  access  the C. diff. Spores and More Global Broadcasting Network Podcast library and listen to topic experts share educational information focused around C. diff. and other healthcare-associated infections.
please  click on the logo below *

cdiffRadioLogoMarch2015

 

 

 

 

 

4-11-16 C Diff Foundation

C. diff. Global Tele-Support Program Welcomes C. diff. Survivors, Patients, Families, Clinicians and All

Posted in Healing by

CdiffGlobalSupportFThe  C. diff. Global Community Tele-Support  program was developed for patients diagnosed with this gastrointestinal infection, for their families, clinicians, C. diff. survivors continuing their recovery from a prolonged illness and any individual seeking support and information are welcome to register.

 

 

C. difficile (C. diff.) infections caused almost half a million infections among patients in the United States in a single year, according to a 2015 study by the Centers for Disease Control and Prevention (CDC). In  addition, an estimated 15,000 deaths are directly attributable to C. difficile infections, making them a substantial cause of infectious disease death in the United States.

These tele-support sessions are focused on:
Nutrition, Mental Health, The Who – What – Where of C. difficile infections,
Fecal Microbiota Transplant (FMT) general information, and more.

The support sessions are lead by fellow-C. diff. Survivors and Healthcare Professionals
with first hand experience and knowledge of topics being discussed.

This program is beneficial to families, patients, and healthcare professionals alike.

Please feel free to offer this program information to others to listen in or participate.
Share the page with friends/family members afflicted with a C. difficile infections
and many other long-term illnesses.

This program is free of charge and available Nationwide and is accessible from 57 Countries.

*To view the complete Country/City Listing please visit the C Diff Foundation Website http://www.cdifffoundation.org  and it can be located under the Top Tab Heading “C diff Support.”

 

Support is never singled out to one diagnosis and is only a phone call away

For the month of  MARCH  the following  Support Sessions are available:

Monday, March 7st:  Host – Angela Martin, a  retired healthcare professional and
fellow-C. diff. Survivor.  Topic:  The session will provide general  information and support related to Fecal Microbiota Transplantation (FMT) as an alternative and promising treatment (not yet FDA approved with clinical data pending), for C. difficile infections (CDI).  Discussions will be focused on information for pre- and post-FMT and failed FMT’s for patients, families, and clinicians worldwide.   Join Angela’s support session on the first Tuesday each month
via: Teleconference at 1:00 p.m. Central Time

Wednesday, March 9th: Host – Lisa Hurka-Covington, a fellow-C. diff. Survivor.
Topic: The session will provide mutual support related to depression and anxiety created by long term illnesses.  Join Lisa to discuss the importance of supporting mental health with physical healthcare on the second  Wednesday each month via: Teleconference at 2:30 p.m.
Eastern Time

Friday, March 11h: Host – Scott Battles, a fellow-C. diff. Survivor.   Topic: The session will provide answers to questions with the introduction to a C. diff. infection.  Join Scott with fellow patients, families, and C. diff.
survivors on the second  Friday each month  via: Teleconference at 7:00 p.m.
Central Time

Colorado Physical Venue Support Group:  Colorado C. diff. Support Group,  Hosted by  a fellow-C.diff. Survivor, Roy Poole,  on the Third Tuesday of each month.  The session will provide discussions about C. diff. introduction, C. diff. Research and development in progress, and hope.  Join Roy and fellow patients, families, and C. diff. survivors  on March 15th at  the Arvada Covenant Church,  5555 Ward Rd , Arvada, CO from 5:30 p.m. – 7:00 p.m
Mountain Time.

Thursday, March 17th: : Host – Karen Factor, MS, RD   Topic: The session  will provide discussions focused on  Nutrition during a C. diff. infection (CDI) and how to manage nutrition and hydration.  Join Karen  the third Thursday each month  via: Teleconference at 7:00 p.m.
Eastern Time

Monday, March 28th: Hosts – Dr’s Caterina Oneto, MD & Dr. Paul Feuerstadt, MD
Topic:  Doctors Oneto and Feuerstadt will discuss C. difficile Infections; The What, Where and How .  There will be opportunities to ask a  brief question to the physicians.  We appreciate Dr.’s Oneto and Feuerstadt for donating their time to discuss C. difficile Infections and to provide information regarding prevention, treatments available, and environmental safety products available.   Join their support session via: Teleconference at 6:00 p.m
Eastern Time

NOTE:  The Physicians will not prescribe, diagnose, or provide medical assessment answers to any individuals participating in their support session.  Please contact the Physician providing care for a C. diff. Infection or other diagnosis that are being treated.    Thank you.

To register for any of the above sessions please provide us with the following information and  you will receive an e-mail in return with the support session Teleconferencing number and Conference ID number.

Or Telephone the office to register   U.S. Hot-Line:  1-844-367-2343,
International: 1-919-201-1512

Thank you for providing your Support Session Choice  to participate in a community support session.

C diff Infection; I Don’t Want To Feel This Way Anymore

Posted in support by

No one understands the pain, the symptoms related to a C.difficile infection (CDI). The symptoms that cause isolation — either because others are afraid to visit or because you’re tied to the restroom or because the body is exhausted from depletion and the constant fluid shift. No, not many truly understand the pain that a body endures during the treatment for a C difficile infection and the healing process —- YOU are not alone and we do understand. For C.difficile infection information and support call the C Diff Foundation’s hot-line and speak with a information specialist today
1-844-FOR-CDIF (1-844-367-2343)

CdiffDontwantto

Warm Holiday Greetings From the C diff Survivors Alliance Network

Posted in support by

chrsitmascardnal

 

The holiday season is upon us; A time to share warm holiday greetings while reflecting upon the many individuals combating a C. difficile infection.

We especially call to mind those who have passed away from a Clostridium difficile infection and/or
C. difficile involvement while fighting other diagnoses simultaneously.

 

 

The all-encompassing nature of chronic illness and its disruption of life and plans can elicit a wide range of emotions. These responses include: stress, grief, anger,fear,depression, and anxiety.  Be kind to yourself.  Take time for you during the holiday season.

Try experimenting with different ways of managing stress and painful emotions. When you find a technique that works, try to incorporate it into your daily or weekly routine. Some ideas include exercising, walking, yoga, listening to music, deep breathing exercise, meditation, cooking, reading, writing in a journal, and spending quality time with family and friends.

We would like to take this opportunity to say that during the year it has been truly appreciated to stand along-side the many patient focused and educational organizations, healthcare professionals, and scientists researching and developing new preventative measures, and treatments to combat C. diff. infections along with the long list of  “superbugs.”

Through continued education and advocating for C. diff. infections and Healthcare-Associated Infections (HAI’s) positive effects are taking place in raising awareness  in prevention, treatments, and environmental safety worldwide.

In 2016 we look forward to releasing newly developed tools for patients, “C. diff. Survivors,” families, healthcare professionals. and residents in every community while  working toward a shared goal in witnessing a reduction of newly diagnosed  C. diff. and Healthcare-Associated Infection (HAI’s) infections.

None of us can do this alone…..all of us can do this together.

Thank you for your continued support and from all of us at the C Diff Foundation, and we wish you and your family warm holiday greetings.

C Diff Foundation Opens a New Avenue – C. diff. Nationwide Community Support Program

Posted in Announcements, C diff Nationwide Community Support Program, support by

CdiffForRelease-1

The C Diff Foundation introduces the                                                                 C. diff. Nationwide Community Support (CDNCS) program beginning in November for patients, families, survivors and for anyone seeking information and support.

C. difficile (C. diff.) infections caused almost half a million infections among patients in the United States in a single year, according to a 2015 study by the Centers for Disease Control and Prevention (CDC).

In addition, an estimated 15,000 deaths are directly attributable to C. difficile infections, making them a substantial cause of infectious disease death in the United States. (See note below [i].)

As of 2015, there is an absence of professional C. diff. (CDI) support groups in America. The                         C Diff Foundation has pioneered a collaborative plan and developed support groups in a variety of availability and locations to meet the needs of individuals seeking C. diff. information and support.

“We found it to be of the utmost importance to implement this new pathway for support and healing after speaking with numerous patients, family members, and fellow-C. diff. survivors,”

The C Diff Foundation now speak for the thousands of patients within the United States who, each year, are diagnosed with a C. diff. infection. This growth, in part, reflects the value C. diff. support groups will provide, not only to patients, their spouses, and families who are living with and recovering from a C. diff. infection, but also to the countless number of individuals who will become more aware of a C. diff. infection, the importance of early detection, appropriate treatments, and environmental safety protocols. There will also be Bereavement support group sessions for  C. diff. survivors mourning the loss of loved ones following their death from C. diff. infection involvement.

Beginning November 2015 the CDNCS groups will be available to all individuals via: Teleconferencing with some groups advancing and adding computer application programs in 2016. CDNCS groups will provide support and information  to 15 participants in each session.

The CDNCS program sessions will be hosted via: Teleconferencing with leaders and fellow C. diff. survivors  from Maryland, Florida, Missouri, Colorado, Ohio, and Oregon.

The Colorado CDNCS group is offered at a public venue and will be hosted in Arvada, Colo. every third Thursday of each month, beginning November 19th. The Meeting will start at 5:30 p.m. and end at 7 p.m lead by a C Diff Foundation Volunteer Advocate and C. diff. survivor  Mr. Roy Poole.

To participate in any CDNCS group being offered during each month, all interested participants will be asked to register through the Nationwide Hot-Line (1-844-FOR-CDIF) or through the  website http://cdifffoundation.org/ where registered individuals will receive a reply e-mail containing support group access information.

  • The Support Registration Page  will be available on November 1st.

The C. diff. Nationwide Community Support group leaders will provide a menu of topics being shared each month on the C Diff Foundation’s website ranging from Financial Crisis Relief, Bereavement, Nutrition, Mental Health, to C. diff. infection updates and everyday life during and after being treated for a prolonged illness. Both Community based sessions and Teleconference sessions will host healthcare profession topic experts

There is evidence that people who attend support group meetings have a better understanding of the illness and their treatment choices. They also tend to experience less anxiety, develop a more positive outlook, and a better ability to cope and adapt to life during and after the treatment for C. diff.

There is a Purpose:

A diagnosis of a C. diff. infection is unexpected and almost always traumatic. As a result, it is not uncommon for newly diagnosed patients to experience a wide range of emotions including, confusion, bewilderment, anger, fear, panic, and denial. Many people find that just having an opportunity to talk with another person, who has experienced the same situation, to help alleviate some of the anxiety and distress they commonly experience.

Individuals also find that they benefit not only from the support they receive, but also from the sense of well-being they gain from helping others. It has been said “support is not something you do for others but rather something you do with others.”

“None of us can do this alone – all of us can do this together.”

Follow the C Diff Foundation on Twitter @cdiffFoundation #cdiff2015 and                                        Facebook https://www.facebook.com/CdiffFoundationRadio.

Note/citation: [i] http://www.cdc.gov/drugresistance/biggest_threats.html