Tag Archives: Infectious disease

Recurrent Clostridium difficile associated diarrhea (rCDAD) Research Study Begins Enrollment

A research consortium across multiple institutions has begun enrolling patients in a clinical trial examining whether fecal microbiota transplantation by enema is safe and effective in preventing recurrent Clostridium difficile-associated disease, according to a press release.

The researchers hope to enroll 162 volunteers aged 18 years or older who have had two or more episodes of C. difficile-associated disease (CDAD) within the past 6 months, according to the release.

Trial sites include Emory University, Duke University Medical Center and Vanderbilt University Medical Center.

Each site is a member of the Vaccine and Treatment Evaluation Unit, which is a network funded by the National Institute of Allergy and Infectious Diseases (NIAID).

The researchers hope to enroll 162 volunteers aged 18 years or older who have had two or more episodes of C. difficile-associated disease (CDAD) within the past 6 months, according to the release.

Clostridium difficile-associated disease, a significant problem in health care facilities, causes an estimated 15,000 deaths in the United States each year,” Anthony S. Fauci, MD, NIAID director, said in the release. “This randomized, controlled trial aims to provide critical data on the efficacy and long-term safety of using fecal microbiota transplants by enema to cure C. diff infections.”

Volunteers will be enrolled in the trial after completing a standard course of antibiotics for a recurrent CDAD episode, presuming their diarrhea symptoms cease on treatment.

Participants will then be randomly assigned to either a group (n = 108) that will take an anti-diarrheal medication and receive a stool transplant (FMT) delivered by retention enema, or a group (n = 54) that will take an anti-diarrheal medication and receive a placebo solution delivered by retention enema.

The placebo is a saline solution that has been colored to mimic an active stool transplant product, to ensure that the study is partially blinded.

Researchers will collect stool and blood samples from participating at designated intervals for a year from the date of effective treatment for CDAD, or from the date of their last treatment if it was unsuccessful, according to the release.

Investigators will evaluate the stool samples for gut microbial diversity and infectious pathogens changes and will examine the blood samples for metabolic syndrome markers.

All participants will be monitored for adverse side effects for 3 years following the completion of recurrent CDAD treatment.

Source:  https://www.healio.com/gastroenterology/infection/news/online/%7B1402ede4-5de1-40a3-b23f-a0070e01ad7a%7D/trial-testing-fmt-for-recurrent-diarrheal-disease-begins

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

Summit Therapeutics plc Outlines Phase 3 Program for Novel C. difficile Infection Antibiotic Ridinilazole

summit

Clostridium difficile Treatment – Phase 3 program outline —

 

SUMMIT OUTLINES PHASE 3 PROGRAMME FOR NOVEL CDI ANTIBIOTIC RIDINILAZOLE FOLLOWING FDA AND EMA REGULATORY MEETINGS

Oxford, UK, On 1 February 2017 – Summit Therapeutics plc
the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection (‘CDI’),  outlines its Phase 3 programme for its novel antibiotic, ridinilazole, following recent regulatory meetings with the US Food and Drug Administration (‘FDA’) and European Medicines Agency (‘EMA’).

With input from the FDA and EMA, Summit intends to design the Phase 3 clinical programme to evaluate superiority of ridinilazole over standard of care in the treatment of C. diffiicle Infection (CDI).

A positive Phase 3 result on superiority has the potential to support the commercial launch of ridinilazole as a differentiated therapy that can both treat initial CDI and reduce disease recurrence.

Mr Glyn Edwards, Chief Executive Officer of Summit commented: “The constructive end of Phase 2 meetings with the US and European regulators have enabled us to design a Phase 3 programme that focuses on evaluating ridinilazole’s superiority over standard of care. This is something we believe would help differentiate our novel class antibiotic from currently marketed CDI treatments and those in late-stage development. Superiority in the combined measure of treatment of initial infection and importantly, reduction in recurrence, could position ridinilazole for front-line treatment of CDI.”
Summit discussed its Phase 3 development programme with the FDA at an End of Phase 2 meeting and through a scientific advice process with EMA. With input from both agencies, the Phase 3 programme is expected to include two trials evaluating ridinilazole as compared to the standard of care, vancomycin, each of which would enrol approximately 700 patients with CDI with the primary endpoint being superiority in sustained clinical response (‘SCR’). Other planned endpoints will include health economic outcome measures. The Phase 3 trial designs are consistent with the successful proof of concept Phase 2 trial, CoDIFy, in which ridinilazole achieved statistical superiority over vancomycin in SCR. SCR is a combined endpoint that measures cure at the end of treatment and a lack of recurrence in the 30 days after treatment. FDA also confirmed that ridinilazole would be eligible for Priority Review based on its QIDP designation.
Mr Edwards continued: “As we continue to evaluate our options to maximize the value of ridinilazole, our stronger financial position following the DMD programme partnership with Sarepta Therapeutics, Inc. means Summit has more time to fully explore all options. These include potentially entering into a collaboration with a third party or securing meaningful non-dilutive funding from government and charitable organizations. In parallel, activities

About Ridinilazole
Ridinilazole is an orally administered small molecule antibiotic that Summit is developing specifically for the treatment of CDI.

In preclinical efficacy studies, ridinilazole exhibited a narrow spectrum of activity and had a potent bactericidal effect against all clinical isolates of C. difficile tested. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin. In this trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. Ridinilazole has received Qualified Infectious Disease Product (‘QIDP’) designation and has been granted Fast Track designation by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include an extension of marketing exclusivity for an additional five years upon FDA approval.

About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialization of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection.

Resources:

http://www.summitplc.com/media/press-releases/

July 19th Join C. diff. Spores and More With Dr. Matthew Henn – Discussing The Role Of the Microbiome In Health and Disease: The Basics

 

Listen To the Live Broadcast

On  July 19th,  2016

cdiffRadioLogoMarch2015CLICK ON THE LOGO TO BE REDIRECTED TO LISTEN TO THE BROADCAST

Listen in to the live broadcast at 10a PT,   11a MT,   12p CT,   1p ET     6p UK


C. diff. Spores and More,”™ Global Broadcasting Network – innovative and educational interactive healthcare talk radio program discusses

This Episode:  

The Role of the Microbiome in Health and Disease: The Basics

With Our Guest

Dr. Matthew Henn,  Senior Vice President, Head of Drug Discovery and Bioinformatics

Matthew Henn is the Senior Vice President and Head of Drug Discovery & Bioinformatics of Seres Therapeutics, Inc. He has more than 16 years of combined research experience in microbial ecology, genomics, and bioinformatics that spans both environmental and infectious disease applications.

Dr. Henn’s research has focused on the development, implementation, and application of genomic technologies in the area of microbial populations and their metabolic functions. Prior to joining Seres, he was the Director of Viral Genomics and Assistant Director of the Genome Sequencing Center for Infectious Diseases at the Broad Institute of MIT and Harvard.

Join us on Tuesday, July 19th as Dr. Henn provides the foundation educational information about the microbiome by answering the fundamental questions of what is it, why is it important, how does it impact patients with C. difficile infections, and what are the possibilities of the microbiome as a therapeutic target for future drugs.  This interview will solely be with Dr. Matthew Henn, Senior Vice President and Head of Drug Discovery & Bioinformatics at Seres Therapeutics, Inc,.

Seres Therapeutics is a leading microbiome therapeutics company dedicated to creating a new class of medicines to treat diseases resulting from imbalances in the microbiome.  These first-in-class drugs, called Ecobiotics®, are ecological compositions of beneficial organisms that are designed to restore a healthy human microbiome. The discovery efforts at Seres Therapeutics currently span metabolic, inflammatory, and infectious diseases.

♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦♦

C. diff. Spores and More ™“ Global Broadcasting Network spotlights world renowned topic experts, research scientists, healthcare professionals, organization representatives,C. diff. survivors, board members, and C Diff Foundation volunteers who are all creating positive changes in the C. diff. community worldwide.

Through their interviews, the C Diff Foundation mission will connect, educate, and empower many worldwide.

Questions received through the show page portal will be reviewed and addressed  by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP,  Dr. Fred Zar is a Professor of Clinical Medicine, Vice HeZarPhotoWebsiteTop (2)ad for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago.  Over the last two decades he has been a pioneer in the study of the treatment of
Clostridium difficile disease and the need to stratify patients by disease severity.

To access the C. diff. Spores and More program page and library, please click on the following link:    www.voiceamerica.com/show/2441/c-diff-spores-and-more

Take our show on the go…………..download a mobile app today

http://www.voiceamerica.com/company/mobileapps

Programming for C. diff. Spores and More ™  is made possible through our official  Sponsor;  Clorox Healthcare

CloroxHealthcare_72

Fecal Transplant Pill Introduced

Clearly a true innovative treatment for the recurrence of C. diff.. During IDWeek 2013, taking place in San Francisco, California, Canadian authors presented the new study and first formal success of fecal transplant pills treating the recurrence of C. diff. infections.

Dr. Thomas Louie, an infectious disease expert from the University of Calgary, found a way to package donated stool into vitamin-sized capsules used to repopulate the intestines of C. diff sufferers with beneficial bacteria. Dr. Louie has treated 27 patients and none had a recurrence of C. diff, even though all of them had had at least four bouts of the infection, which can lead to severe disease or death.

Quoted from the article:
Fecal transplant experts at the University of Minnesota have had some success with freezing fresh stool, and some suggest that freeze-drying the organisms might be a way to preserve it for wider use. Dr. Cliff McDonald, a C. diff expert at the CDC, said Louie’s work represents further innovation in the potentially life-saving treatment for the infections. “The idea has been held by a few for a number of years, but no one else I am aware of is actually doing it this way other than Dr. Louie,” he said.

Dr. Colleen Kraft, who performs fecal transplants at the Emory University School of Medicine, agreed.
“This is clearly the future of fecal transplant therapy,” she told NBC News. “And there are many poised in the market to support this type of therapy and related synthetic bacteriotherapy. I do not see any drawbacks if it is indeed efficacious.”

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

http://www.nbcnews.com/health/poop-pills-are-latest-way-cure-dangerous-c-diff-infections-8C11300066