Tag Archives: Recurrent C diff Infection

Researchers Find Health Care Costs Associated With a Clostridium difficile Infection (CDI) and Recurrent CDI Shows a Significant Increase

 

“This study is consistent with previous literature that has demonstrated a significant and substantial increase in health care resource utilization for CDI over and above similar patients without CDI,” researcher Dongmu Zhang, PhD, of Merck’s Center for Observational and Real-World Evidence, and colleagues wrote. “It has also shown that having rCDI is associated with substantial health care resource use as compared to similar CDI patients who do not have a recurrence.”

To estimate costs and time of hospitalization associated with CDI and rCDI, the researchers conducted a retrospective observational study. They assessed patient records using databases of commercial and Medicare health care claims. Both databases included information on demographics, diagnoses and prescriptions, among other data.

The researchers matched patients without CDI to those with the infection in a 1:1 ratio to estimate costs and lengths of hospital stay due to primary CDI. They then matched patients with primary CDI 1:1 to those with rCDI in a similar comparison. Each patient was followed for 6 months.

The study included records for 55,504 patients diagnosed with CDI between

July 2010 and July 2014.

The mean patient age was 61.3 years,

62% of patients were women.

Nearly a quarter of patients — 24.8% — had rCDI.

The estimated cumulative hospital stays due to CDI and rCDI were 5.2 days and 1.95 days, respectively.

The estimated health care costs due to CDI and rCDI were $24,205 and $10,580, respectively.

Zhang and colleagues said the data show that clinicians must act to control CDI.

“The health care resource utilization and economic burden associated with primary and rCDI are quite substantial,” they wrote. “Better prevention and treatment of CDI, especially rCDI, are needed.” – by Joe Green

 

To read the article in full entirety please click on the following link:

https://www.healio.com/infectious-disease/nosocomial-infections/news/in-the-journals/%7Bce566ea4-98f0-41d3-a8a3-6e0f2125e3dc%7D/cdi-costs-approach-25000-per-patient

Rebiotix and the C Diff Foundation Applaud the State of Minnesota as it Declares November C. difficile Infection Awareness Month

 Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, and the C Diff Foundation have joined today to voice support for the State of Minnesota in declaring November “C. difficile Infection Awareness Month.

Rebiotix and the C Diff Foundation believe this important action by Governor Mark Dayton and his administration adds significant weight to the ongoing effort to prevent and treat Clostridium difficile infection (C. diff.), which is a national health concern resulting in more than 500,000 infections and 29,000 deaths annually.

C. diff infection is a debilitating and potentially life-threatening condition that is now recognized as the number one healthcare associated infection in the U.S.,” said Lee Jones, president and CEO of Rebiotix.  “Increasing the awareness of this disease is important.  We applaud both the C Diff Foundation and the State of Minnesota in its effort to build awareness of this significant health concern and welcome the opportunity to be at the forefront of developing a potentially new treatment for patients to address the most challenging of C. diff infections.”

Rebiotix’s first product, RBX2660,  is intended to prevent recurrent C. diff infections. RBX2660 is currently the subject of a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate its efficacy and safety for the prevention of recurrent C. diff infection and is Rebiotix’s most clinically advanced drug product developed from the company’s Microbiota Restoration Therapy™ (MRT) platform.   Rebiotix is also advancing RBX7455, a lyophilized, non-frozen, oral capsule formulation of its MRT technology in an investigator sponsored Phase 1 study for the prevention of recurrent C. diff infection.

“The ability to prevent and potentially eradicate recurrent C. diff infection requires leadership from across the landscape of healthcare, from government institutions to advocacy to academia to emerging biotechnology companies,” said Nancy Caralla, founder of the C Diff Foundation.  “We commend the State of Minnesota and Rebiotix as each seeks to play an important role in reducing the rate and impact of C. diff infection.”

About Clostridium difficile Infection
Clostridium difficile (C. diff.) infection is a serious and potentially fatal gastrointestinal disease, characterized by severe diarrhea, fever, and loss of appetite. It is a leading healthcare-associated infection (HAI), and in the U.S. alone, there are about 500,000 people infected and over 29,000 deaths annually from the disease. Currently, 20-30% of patients with C. diff. go on to experience more than one episode of the disease, which is known as recurrent C. diff. infection. Recurrent C. diff. infection is especially challenging to treat as, to date, there are no approved microbial-based drugs to treat patients with two or more recurrences.

About the C Diff Foundation
The 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, environmental safety, and support worldwide.  The Foundation’s founder is a Nurse and after suffering through C. difficile infections herself and witnessing the loss of her Father, whose life was claimed by C. difficile involvement, the C Diff Foundation came to fruition.  The C Diff Foundation Members, with  their Volunteer Patient Advocates, successfully “Raise C. diff. Awareness”  nationwide and in fifty-six  (56) countries and host a U.S. Nationwide information Hot-Line (1-844-FOR-CDIF) to support health care providers, patients, and families manage through the difficulties of a C. diff. infection among many other programs.

About Rebiotix Inc.
Rebiotix Inc. is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix possesses a deep and diverse clinical pipeline, with its lead drug candidate, RBX2660, in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff) infection.  RBX2660 has been granted Fast Track status and Breakthrough Therapy designation from the FDA for its potential to prevent recurrent C. diff. infection. Rebiotix’s clinical pipeline also features RBX7455, a lyophilized non-frozen, oral capsule formulation, which is currently the subject of an investigator-sponsored Phase 1 trial for the prevention of recurrent C. diff. infection.  In addition, Rebiotix is targeting several other disease states with drug products built on its pioneering Microbiota Restoration Therapy (MRT) platform.  MRT 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 via a ready-to-use and easy-to-administer format. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com.

Multiple Recurring Clostridium difficile infections (mrCDI) Data From 2001-2012 Study

Article from the Lancashire Post, July 4, 2017

To read the article in its entirety, please click on the following link:

http://www.lep.co.uk/news/offbeat/cases-of-clostridium-difficile-soaring-1-8630398

 

mrCDI (multiple recurring C. difficile infections), they are the most difficult to treat and are rapidly becoming more common, say scientists.

* also referred to  as rCDI, recurring CDI

In the US between 2001 and 2012 the annual rate rose by almost 200 per cent more than four times the increase in ‘ordinary’ C. diff.

The bug, which can kill elderly patients, most commonly affects those who have recently been treated with antibiotics.

The precise reasons for the sharp rise in mrCDI’s incidence is so far unknown but adds strain to healthcare systems with an urgent need for new treatments.

FMT has shown good results in small studies in the war on C. diff but hasn’t yet been thoroughly evaluated.

Professor James Lewis, of Pennsylvania University, said: “The increasing incidence of C. difficile being treated with multiple courses of antibiotics signals rising demand for faecal microbiota transplantation in the United States.

 

“While we know faecal microbiota transplantation is generally safe and effective in the short term, we need to establish the long term safety of this procedure.”

C.diff is a bacterium that causes inflammation of the colon, a condition called colitis. Symptoms include diarrhoea, fever, loss of appetite, nausea and abdominal pain.

Recurrent C.diff, a bout within 90 days of the last, is a major problem with the risk of contracting it again at 50-60 per cent after three or more infections.

 

The bacteria are found in faeces, and people can become infected if they touch items or surfaces that are contaminated and then touch their mouths or mucous membranes.

Burden On Healthcare Systems

C. diff afflicts half a million Americans a year causing tens of thousands of deaths and costing the nation’s healthcare system an estimated $5 billion.

The study published in the Annals of Internal Medicine identified the alarming trend by analysing a nationwide health insurance database with the records of more than 40 million US patients.

Cases of C. diff were considered to have multiple recurrences when doctors treated them with at least three closely spaced courses of antibiotics.

According to the analysis, the incidence of C diff rose by about 43 percent over the study period, compared to 189 percent for mrCDI.

Older females more susceptible

The latter group were more likely to be older with an average age of 56, seven years more than the former’s 49 and were more likely to be female (64 per cent vs. 59 percent.

They were also more likely to have been exposed previously to medications such as corticosteroids, heartburn drugs known as PPIs (proton-pump inhibitors) and antibiotics.

The rapid rise in the incidence of mrCDI may be due in part to Americans’ increasing use of such drugs. But Prof Lewis said other causes are also likely.

He said: “An additional driver of this rise in incidence could be the recent emergence of new strains of C. difficile, such as NAP1, which has been shown to be a risk factor for recurrent CDI.”

C.diff is notorious for spreading among vulnerable patients within hospitals and can lead to fatal blood infections (sepsis) – especially among the elderly.

The antibiotics metronidazole, vancomycin, and fidoxamicin are commonly used to treat CDI……….

Long used in veterinary medicine, FMT is an alternative to antibiotics and involves infusions of foecal matter from healthy intestines.

The aim is to help restore a normal gut bacteria population in the patient and thereby discourage C. diff growth.

But Prof Lewis said despite such promising results more needs to be known about FMT’s long-term safety – and the fast-rising incidence of mrCDI underscores this need.

The American Gastroenterological Association recently set up a formal registry for doctors to report their results with FMT procedures.

Prof Lewis said: “It’s a way in which practitioners who are performing faecal microbiota transplantation can contribute data to help answer these critical questions.”

A small study in 2013 found a single FMT infusion cleared up diarrhoea in 81 percent of the recurrent-CDI patients who received it. On the other hand the standard antibiotic vancomycin worked for just 31 percent.

 

Seres Therapeutics SER-109 Phase 3 Clinical Study For Recurrent C. diff. Infection Initiated

Seres Therapeutics Initiates SER-109 Phase 3 Study in Patients with Multiply

Recurrent C. difficile Infection

 

Jun. 12, 2017– Seres Therapeutics, Inc.

announced the initiation of its Phase 3 SER-109 clinical study (ECOSPOR III) in patients with multiply recurrent C. difficile infection. Based on recent interactions with the U.S. Food and Drug Administration (FDA), ECOSPOR III will now be designated a Phase 3 trial and the company expects that this single pivotal study may support SER-109 registration and approval.

“We are extremely pleased to be able to initiate the SER-109 Phase 3 ECOSPOR III study. If ECOSPOR III is successful, we believe this study could serve as the basis for SER-109 approval. Our goal is to have SER-109 approved as the first microbiome drug in this new field of medicine, and the first for patients with multiply recurrent C. difficile infection, an area of very high unmet need for patients in the U.S. and around the world,” said Roger J. Pomerantz, M.D., President, CEO and Chairman of Seres.

The ECOSPOR III Phase 3 study design incorporates direct learnings from prior SER-109 development efforts, as well as helpful feedback obtained from the FDA and study investigators. The study is expected to enroll approximately 320 patients with multiply recurrent C. difficile infection, randomized 1:1 to either SER-109 or placebo. The study is sized to contribute to an adequate safety database that may support product licensure. ECOSPOR III will utilize more than 100 clinical sites across the U.S. and Canada. The study’s primary endpoint will compare the reduction of C. difficile recurrence rates in subjects who receive SER-109 verses placebo at up to eight weeks after dosing.

The initiation of the SER-109 Phase 3 ECOSPOR III study triggers a $20 million milestone payment under the company’s previously announced development and commercialization collaboration agreement with Nestlé Health Science. In partnership with Nestlé Health Science, Seres plans to accelerate interactions with European regulatory agencies in the coming months to establish a path toward SER-109 product approval across Europe.

About SER-109 and C. difficile Infection

SER-109, an oral capsule, is Seres’ lead Ecobiotic® microbiome therapeutic for the treatment of multiply recurrent C. difficile infection. SER-109 is a biologically sourced consortium of bacterial spores designed to catalyze a shift in a dysbiotic gastrointestinal microbiome to a healthier state. The FDA has granted SER-109 both Breakthrough Therapy and Orphan Drug Designations.

C. difficile infection is one of the top three most urgent antibiotic-resistant bacterial threats in the United States according to the Centers for Disease Control. C. difficile is a leading cause of hospital acquired infection in the U.S. and is responsible for the death of approximately 29,000 Americans each year.

To read the article in its entirety please visit Seres Therapeutics Website:

http://serestherapeutics.com/about

Rebiotix a Clinical Stage Microbiome Company Shared RBX2660 and RBX7455 Clinical Study Data At ASM Microbe 2017


Rebiotix Inc a clinical stage microbiome company focused on
harnessing the power of the human microbiome to treat challenging diseases, announced that it presented three posters during the American Society for Microbiology’s ASM Microbe 2017, held

June 1-5, 2017 in New Orleans.

Two posters include microbiome data analyses from a randomized placebocontrolled
Phase 2b clinical study featuring RBX2660,

Rebiotix’s Phase 3-ready broad-spectrum
microbiota suspension designed to rehabilitate the human microbiome by delivering live microbes into a patient’s intestinal tract to treat disease.

A third poster was also presented showing a meta analysis
of placebo response rates  among recurrent Clostridium difficile clinical trials, which provides a field benchmark for future clinical studies.

“The two microbiome analysis posters presented during ASM Microbe 2017 were very important in illustrating the ability of RBX2660 to potentially rehabilitate the microbiome of patients with C. difficile infections.  Two separate data analyses from the PUNCH CD2 Phase 2b clinical trial of RBX2660 demonstrated that patients successfully treated with RBX2660 exhibited microbiomes that more closely  align with healthy subjects, and that one dose of RBX2660 is sufficient to induce microbiome changes  associated with successful outcomes,” stated Lee Jones, president and CEO of Rebiotix.

The poster titled “Changing the Microbiome: Patients with a Successful Outcome Following Microbiota- Based RBX2660 Treatment Trend Toward Human Microbiome Project Healthy Subjects’ Profile,”   detailed the results of the PUNCH CD2 Phase 2b trial of the microbiome-based drug, RBX2660.

In this trial, a single dose of RBX2660 demonstrated a significantly better treatment response rate of preventing recurrent Clostridium difficile infections than placebo (67% vs 46%, respectively; p = 0.048).

In a further analysis, investigators determined that patient microbiomes became more diverse and more closely aligned to a healthy microbiome as defined by the Human Microbiome Project (HMP) after treatment with RBX2660, with the largest shift occurring seven days after treatment. 2  The second poster, titled “Resetting the Microbial Landscape: Donor Microbiome Engraftment in  Patients Treated with RBX2660 for Multi-Recurrent Clostridium difficile Infection,” further elaborated on  the shift of the patient microbiome profile towards the profile of RBX2660. In this poster, 16S rRNA sequencing was performed on stool samples collected from 42 subjects in the RBX2660 treatment arm and 19 RBX2660 drug lots. The RBX2660 microbial profiles had similar taxonomic distributions, with a
group mean that was highly divergent and significantly different from patient baseline microbiome  profiles. After RBX2660 treatment, the patients’ microbiomes progressively shifted to more closely  resemble RBX2660, with the largest shift occurring 7 days after treatment. Further work is planned to  define specific taxa and strains that directly engraft from RBX2660 to the patient. Importantly, this study  also confirmed that one dose of RBX2660 is sufficient to support the microbiome change associated
with successful outcome.

About Rebiotix Inc.
Rebiotix Inc. is a clinical-stage microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix is the most clinically  advanced microbiome company in the industry, with its lead drug candidate, RBX2660, expected to  enter Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff) infection.

RBX2660 has been granted Fast Track status and Breakthrough Therapy designation from the FDA for  its potential to prevent recurrent C. diff. infection.

Rebiotix’s clinical pipeline also features RBX7455, a room temperature stable oral capsule formulation, which is currently the subject of an investigator sponsored  Phase 1 trial for the prevention of recurrent C. diff. infection. In addition, Rebiotix is targeting  several other disease indications with drug products built on its pioneering Microbiota Restoration Therapy (MRT) platform.

MRT is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s  intestinal tract via a ready-to-use and easy-to-administer format. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com

Rebiotix Reports Topline Results From a Controlled Open-label Phase 2 Trial of RBX2660 (PUNCH™ Open Label) For the Prevention of Recurrent Clostridium difficile (C. diff.) Infection (rCDI)

In The News

April 2017

 

 

Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, today announced topline results from a controlled open-label Phase 2 trial of RBX2660 (PUNCH™ Open Label) for the prevention of recurrent Clostridium difficile (C. diff.) infection.

Data indicated that RBX2660 was well-tolerated and achieved the primary efficacy endpoint of preventing C. diff. recurrence; patients treated with RBX2660 exhibited a treatment success rate of 78.8% compared with a historical control of 51.8% (p<0.0001). RBX2660 is a broad-spectrum microbiota suspension that is designed to rehabilitate the human microbiome by delivering live microbes into a patient’s intestinal tract to treat disease.

Lee Jones, president and CEO of Rebiotix, stated, “The 78.8% treatment success achieved in this open label Phase 2 trial demonstrates the potential of RBX2660, a broad spectrum microbiota drug product, to rehabilitate the gut microbiome and break the cycle of C. diff. recurrence. These results, coupled with the safety and efficacy data observed in our prior Phase 2b and Phase 2 clinical trials, position Rebiotix to advance RBX2660 into Phase 3 clinical development, solidifying our standing as the most clinically advanced microbiome company in the industry.”

PUNCH™ Open Label was designed as a prospective, multicenter, open-label, controlled Phase 2 study to assess the efficacy and safety of RBX2660 for the prevention of recurrent C. diff.

The primary efficacy endpoint involved a comparison of patients treated with RBX2660 to a closely matched set of antibiotic only treated historical controls through 56 days. There were 31 active treatment sites and four control sites in the US and Canada. 132 RBX2660 and 110 historical control subjects were included in this topline analysis.

Actively treated patients, after determining eligibility, were administered two doses of RBX2660; the first at day one and the second at day seven. Patients were then monitored for eight weeks to determine whether there was a recurrence of C. diff.

Top line results from the trial, which examined responses from 132 patients versus a historical control of 110 patients, indicated a treatment success rate of 78.8% as compared to a historical control of 51.8% (p<0.0001). Overall, RBX2660 was generally well-tolerated with the most commonly reported adverse events being gastrointestinal, including diarrhea, abdominal pain, flatulence, constipation and distension.


About Rebiotix Inc.

Rebiotix Inc. is a clinical-stage microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix is the most clinically advanced microbiome company in the industry, with its lead drug candidate, RBX2660, expected to enter Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff.) infection. Previously, RBX2660 was the subject of three Phase 2 trials in recurrent C. diff, including a Phase 2b randomized, double-blind, placebo-controlled trial (PUNCH™ CD2), with data indicating the drug was well-tolerated and demonstrated statistically significant treatment efficacy. RBX2660 has been granted Orphan Drug status, Fast Track status and Breakthrough Therapy Designation from the FDA for its potential to prevent recurrent C. diff. infection.

Rebiotix’s development pipeline includes multiple formulations targeting several disease indications and is built around its pioneering Microbiota Restoration Therapy (MRT) platform. MRT is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format.

For More Information About C. difficile Clinical Trials In Progress : 

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

 

For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com

 

Source:  Rebiotix 4/17

The Power Of Microbes In Recurrent C.diff. Infection (CDI) 94%-96% Cure Rates

Microscope - 5

“Treating patients with recurrent C. difficile infection with microorganisms alone provides cure or reduction of symptoms at a rate many times higher than any drug or chemical that has ever been looked at. These cure rates of 94% and 96% are astronomical, and it is all due to the power of microbes, ” said Michael Sadowsky, PhD, Director of the BioTechnology Institute at the University of Minnesota, St. Paul, Minnesota.

“I think the future of medicine in the 21st century is to use the power of microbes to cure diseases.”

This new work, published in mBio, an open access journal of the American Society for Microbiology, has found which microbes are most effective in the fecal transplant procedure. The microbes from donor samples were purified and transplanted into patients to find which conferred the most benefit. The researchers used next-generation sequencing to assay the microbial populations of patients and donors.

Their findings surprised them; while they met expectations by curing around 90 percent of patients, some people who had received a placebo treatment, made up of their own fecal sample, were also cured. The researchers were able to determine that the patients cured by placebo already had some types of curative bacteria in their guts, strains that were boosted when they got the placebo.

“As opposed to what we thought, complete engraftment of microbiota is not required to cure a patient,” said Sadowsky.

“The study provides insight into which microorganisms are the most important for curing C. difficile and may allow clinicians to better tailor therapy, by improving donor material to facilitate a more rapid, effective, and lasting cure.”

Scientists can use this new data to optimize their treatments. “This paper provides us data with which microbes to supplement into our preparations,” Sadowsky concluded.

To read the article in its entirety click on the following link to be redirected:

https://www.labroots.com/trending/microbiology/4839/understanding-improving-fecal-microbiota-transplants?utm_content=buffer081c1&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer