Tag Archives: C. difficile treatment

CutisPharma Partners With C Diff Foundation To Support C.difficile Infection Awareness and Advocacy Efforts

 

CutisPharma and the C Diff Foundation announced the launch of a partnership beginning on November 1, 2017, the first day of Clostridium difficile awareness month.  As part of the partnership, CutisPharma awarded an unrestricted grant to the Foundation to further support its awareness efforts.

“We are pleased to partner with the C Diff Foundation and support its education and advocacy efforts benefiting patients impacted by Clostridium difficile Infection,” said Neal I. Muni, MD, MSPH, Chief Executive Officer of CutisPharma.  “It’s our hope that our work together can make positive strides in building awareness of this life-threatening condition that affects over a half-million patients in the United States annually.”

The nonprofit C Diff Foundation is dedicated to supporting global public health initiatives for Clostridium difficile Infection (CDI), also called C. difficile or C. diff – for infection prevention, treatments and environmental safety.

“We are very thankful for CutisPharma’s support of our foundation’s efforts,” said Nancy Caralla, Foundress and Executive Director of the C Diff Foundation, who is both a nurse and a three-time C. difficile survivor who also lost her father to a C. difficile infection.  “CutisPharma’s mission to improve the lives of patients with unmet medical needs is aligned with our foundation’s goals, and we look forward to partnering with Neal and his team to further our education and advocacy efforts on behalf of patients and survivors.”

CutisPharma has undertaken several initiatives to expand from its traditional base of making compounding kits for pharmacists, including the development and commercialization of FDA-approved drugs. The filing of the Company’s first FDA New Drug Application earlier this year, by its RM Therapeutics subsidiary, was a key milestone in the Company’s expansion goals.

About CutisPharma

CutisPharma, Inc., based in Wilmington, Mass., is a privately held, specialty pharmaceutical company that has historically developed and distributed kits used by pharmacists to safely create compounded medications for nearly 20 years.  The Company’s products include oral solutions and suspensions, such as antimicrobials, mouthwashes, and PPIs; topicals, including hydrocortisone; and suppositories, including progesterone VGS.  CutisPharma’s FIRST Unit-of-Use Kits have benefited millions of patients who are unable to swallow conventional oral dosage forms such as tablets and capsules and whose needs are not served by commercially available therapies.  For more information, visit www.cutispharma.com.

ZINPLAVA (bezlotoxumab) Is Now Available For Prescription To Reduce Recurrence Of Clostridium difficile Infection (CDI)

ZINPLAVA (bezlotoxumab) is now available for prescription.

Ordering information is available on the brand website:

http://www.zinplava.com/

What is Zinplava ?

ZINPLAVA is indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence.

ZINPLAVA is not indicated for the treatment of CDI.

ZINPLAVA is not an antibacterial drug.

ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.

Full prescribing information can be read at

http://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_pi.pdf

The Merck Access Program can help answer physician’s questions about:
Insurance coverage for patients
Prior Authorizations and Appeals
Coding and Billing
Potential financial assistance options for eligible patients

Full program details can be found at:

https://www.merckaccessprogram-zinplava.com/hcp/

Also, Information about co-pay assistance for eligible, privately insured patients
Information about available independent assistance foundation support.

 

*PLEASE NOTE – The C Diff Foundation does not endorse any product, medication,  and/or clinical study in progress and available.     All website postings are strictly for informational purposes only.

 

Clostridium difficile (C.diff.) Infection (CDI) Rates In the United States and Across the Globe Have Increased In the Last Decade, Along With Associated Morbidity and Mortality

 

 

Early Diagnosis, Prevention, and Treatment of Clostridium difficile: Update

Prepared for:
Agency for Healthcare Research and Quality
U.S. Department of Health and Human Services
5600 Fishers Lane
Rockville, MD 20857
March 2016

 

Clostridium difficile is a gram-positive, anaerobic bacterium generally associated through ingestion. Various strains of the bacteria may produce disease generating toxins
and TedA and TedB, as well as the lesser understood binary toxin.

Our use of the term indicates this review’s focus is the presence of clinical disease rather than asymptomatic carriage of C. difficile CDI symptoms can range from mild diarrhea to severe cases including pseudomembranous colitis and toxic megacolon and death.

Estimated U.S. health care associated CDI incidence in 2011 was 95.3 per 100,000, or about
293,000 cases nationally. Incidence is higher among females, whites, and persons 65 years of
age or older. (1)

About one third to one half of health-care onset CDI cases begin in long term care,thus residents in these facilities are at high risk.  Incidence rates may increase by four or five-fold during outbreaks.

Community associated CDI, where CDI occurs outside the institutional setting,
is also on the rise, though still generally lower than institution associated rates and may be in part due to increased surveillance. Estimated community associated CDI was 51.9 per 100,000, or   159,700 cases in 2011.  (1)

Community-associated CDI complicates measuring the effectiveness of  prevention within an institutional setting. 3  Additionally, the pathogenesis of CDI is complex and not
completely understood, and onset may occur as late as several months after hospitalization or antibiotic use

The estimated mortality rate for health -care associated CDI ranged from 2.4 to 8.9 deaths per

100,000 population in 2011.(1) For individuals ≥65 years of age, the mortality rate
was 55.1 deaths per 100,000; (1)

CDI was the 17th leading cause of death in this age group (4)
Hypervirulent C. difficile  strains have emerged since 2000 . These affect a wider population

that includes children, pregnant women, and other healthy
adults, many of whom lack standard risk profiles such as previous hospitalization or antibiotic use.(5)

The hypervirulent strains  account for 51 percent of CDI, compared to only 17 percent
of historical isolates. (6)

Time from symptom development to septic shock may be reduced in the hypervirulent strains, making quick diagnosis and proactive treatment regimens critical for positive outcomes.

To read more on  TREATMENT, PREVENTION, KEY QUESTIONS ——

https://www.effectivehealthcare.ahrq.gov/ehc/products/604/2208/c-difficile-update-report-160329.pdf

Early Diagnosis, Prevention, and Treatment of Clostridium difficile: Update

Prepared for:
Agency for Healthcare Research and Quality
U.S. Department of Health and Human Services
5600 Fishers Lane
Rockville, MD 20857
March 2016

 

Sources:

1Appendix J. References for Appendixes
1.Alcala L, Reigadas E, Marin M, et al.
Comparison of GenomEra C. difficile and Xpert
C. difficile as confirmatory tests in a multistep
algorithm for diagnosis of Clostridium difficile
infection.
J Clin Microbiol 2015 Jan;53(1):332
5. PMID: 25392360.
2.Barkin JA, Nandi N, Miller N, et al.
Super iority
of the DNA amplification assay for the
diagnosis of C. difficile infection: a clinical
comparison of fecal tests.
Dig Dis Sci 2012Oct;57(10):2592-
9. PMID: 22576711.
3.Bruins MJ, Verbeek E, Wallinga JA, et al.
Evaluation of three enzyme immunoassay
s and a loo mediated isothermal amplification test
for the laboratory diagnosis of Clostridium
difficile infection. Eur J Clin Microbiol Infect
Dis 2012 Nov;31(11):3035 9. PMID:
22706512.
4.Buchan BW, Mackey TL, Daly JA, et al.
Multicenter clinical evalu
ation of the portrait
toxigenic C. difficile assay for detection of
toxigenic Clostridium difficile strains in clinical
stool specimens. J Clin Microbiol 2012
Dec;50(12):3932-
6. PMID: 23015667.
5.Calderaro A, Buttrini M, Martinelli M, et al.
Comparative analysis of different methods to
detect Clostridium difficile infection. New
Microbiol 2013 Jan;36(1):57-
63. PMID:
23435816.
6.Carroll KC, Buchan BW, Tan S, et al.
Multicenter evaluation of the Verigene
Clostridium difficile nucleic acid assay.
J ClinMicrobiol 2013 Dec;51(12):4120-
5. PMID:24088862

C Diff Foundation Welcomes Dr. Caterina Oneto, MD

 

We are pleased to welcome Dr. Caterina Oneto, MD to the
C Diff Foundation. 

Dr. Oneto presides as a Medical Advocate for the  
C. diff. Nationwide Community Support Program teleconferencing sessions.

 

 

Dr. Caterina Oneto is a Clinical Assistant Professor within the NYU Division of Gastroenterology, Board Certified in Gastroenterology and Internal Medicine. 

Fluent in Spanish, she graduated with a degree in Medicine and Surgery from the
Universidad de Valparaiso in Chile. She completed her residency in
Internal Medicine at Cabrini Medical Center, where she served also as Chief Resident, and later completed her Fellowship in Gastroenterology at Montefiore Medical Center, Albert Einstein College of Medicine. 

With expertise in endoscopy, colonoscopy, capsule endoscopy, liver and pancreatic diseases, Dr. Oneto’s special interests include IBD (Crohn’s disease and Ulcerative Colitis), IBS (irritable bowel syndrome), microbiota modification, treatment of Clostridium Difficile and FMT (Fecal Microbiota Transplantation). 

Fecal Microbiota Transplant – Study Provides Insight Into Structural/Metabolic Changes That Occur After FMT

Fecal microbiota transplantation

The process of delivering stool bacteria from a healthy donor to a patient suffering from intestinal infection with the bacterium Clostridium difficile  works by restoring healthy bacteria and functioning to the recipient’s gut, according to a study published this week in mBio®, the online open-access journal of the American Society for Microbiology.

The study provides insight into the structural and potential metabolic changes that occur following fecal transplant, says senior author Vincent B. Young, MD, PhD, an associate professor in the Department of Internal Medicine/Infectious Diseases and the Department of Microbiology & Immunology at the University of Michigan in Ann Arbor. The transplants, which have been successful at curing more than 90 percent of recipients, have been used successfully since the 1950s, he says, though it hasn’t been clear how they work to recover gut function.

“The bottom line is fecal transplants work, and not by just supplying a missing bug but a missing function being carried out by multiple organisms in the transplanted feces,” Young says. “By restoring this function, C. difficile isn’t allowed to grow unchecked, and the whole ecosystem is able to recover.”

Young and colleagues used DNA sequencing to study the composition and structure of fecal microbiota (bacteria) in stool samples from 14 patients before and two to four weeks after fecal transplant. In 10 of the patients, researchers also compared stool samples before and after transplant to samples from their donors.

All transplant patients, treated at the Essentia Health Duluth Clinic in Minnesota, had a history of at least two recurrent C. difficile infections following an initial infection and failed antibiotic therapy.

Studying families of bacteria in the samples, investigators found marked differences among donor, pre-transplant and post-transplant samples. However, those from the donors and post-transplant patients were most similar to each other, indicating that the transplants at least partially returned a diverse community of healthy gut bacteria to the recipients. While not as robust as their donors, the bacterial communities in patients after transplant showed a reduced amount of Proteobacteria, which include a variety of infectious agents, and an increased amount of Firmicutes and Bacteroidetes bacteria typically found in healthy individuals, compared to their pre-transplant status.

Then, using a predictive software tool, researchers analyzed the relationship between the community structure of the micoorganisms and their function, presumably involved in maintaining resistance against CDI.

They identified 75 metabolic/functional pathways prevalent in the samples. The samples taken from patients before transplant had decreased levels of several modules related to basic metabolism and production of chemicals like amino acids and carbohydrates, but were enriched in pathways associated with stress response, compared to donor samples or post-transplant samples.

CDI has significantly increased during the past decade, Young says, with previous studies estimating there are more than 500,000 cases of CDI in the United States annually, with health care costs ranging from $1.3 billion to $3.4 billion. Up to 40 percent of patients suffer from recurrence of disease following standard antibiotic treatment. In a healthy person, gut microorganisms limit infections but antibiotics are believed to disrupt the normal structure of these microoganisms, rendering the gut less able to prevent infection with C. difficile.

Further identification of the specific microorganisms and functions that promote resistance of bacterial colonization, or growth, may aid in the development of improved CDI treatments, Young says: “If we can understand the functions that are missing, we can identify supplemental bacteria or chemicals that could be given therapeutically to help restore proper gut function.”

For article in its entirety click on the link below:

http://www.eurekalert.org/pub_releases/2014-06/asfm-ftr061214.php

 

The study was supported by the National Institutes of Health, the Michigan Gastrointestinal Peptide Research Center, and the Essentia Health Foundation in Duluth, Minn.

mBio® is an open access online journal published by the American Society for Microbiology to make microbiology research broadly accessible. The focus of the journal is on rapid publication of cutting-edge research spanning the entire spectrum of microbiology and related fields. It can be found online at http://mbio.asm.org.

The American Society for Microbiology is the largest single life science society, composed of over 39,000 scientists and health professionals. ASM’s mission is to advance the microbiological sciences as a vehicle for understanding life processes and to apply and communicate this knowledge for the improvement of health and environmental and economic well-being worldwide.