Clostridium difficile infection is the most common health-care-associated infection in the USA. We assessed the safety and efficacy of ridinilazole versus vancomycin for treatment of C difficile infection.
We did a phase 2, randomized, double-blind, active-controlled, non-inferiority study. Participants with signs and symptoms of C difficile infection and a positive diagnostic test result were recruited from 33 centres in the USA and Canada and randomly assigned (1:1) to receive oral ridinilazole (200 mg every 12 h) or oral vancomycin (125 mg every 6 h) for 10 days. The primary endpoint was achievement of a sustained clinical response, defined as clinical cure at the end of treatment and no recurrence within 30 days, which was used to establish non-inferiority (15% margin) of ridinilazole versus vancomycin. The primary efficacy analysis was done on a modified intention-to-treat population comprising all individuals with C difficile infection confirmed by the presence of free toxin in stool who were randomly assigned to receive one or more doses of the study drug. The study is registered with ClinicalTrials.gov, number NCT02092935.
Between June 26, 2014, and August 31, 2015, 100 patients were recruited; 50 were randomly assigned to receive ridinilazole and 50 to vancomycin. 16 patients did not complete the study, and 11 discontinued treatment early. The primary efficacy analysis included 69 patients (n=36 in the ridinilazole group; n=33 in the vancomycin group). 24 of 36 (66·7%) patients in the ridinilazole group versus 14 of 33 (42·4%) of those in the vancomycin group had a sustained clinical response (treatment difference 21·1%, 90% CI 3·1–39·1, p=0·0004), establishing the non-inferiority of ridinilazole and also showing statistical superiority at the 10% level. Ridinilazole was well tolerated, with an adverse event profile similar to that of vancomycin: 82% (41 of 50) of participants reported adverse events in the ridinilazole group and 80% (40 of 50) in the vancomycin group. There were no adverse events related to ridinilazole that led to discontinuation.
Ridinilazole is a targeted-spectrum antimicrobial that shows potential in treatment of initial C difficile infection and in providing sustained benefit through reduction in disease recurrence. Further clinical development is warranted.
Wellcome Trust and Summit Therapeutics.
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Raising global awareness with leading international topic experts have proven to be effective over the years with audiences attending our annual conferences.
The Global C. difficile Congress took place on November 11th, 2016 and broadened existing knowledge surrounding C. difficile infection (CDI) prevention, treatments, research, and environmental safety worldwide.
The drive and passion takes us forward in promoting the practical and technical advancements taking place across the globe. Healthcare Professionals from every area of expertise, discussed the control and treatment options, the healthcare perspectives, antibiotic-resistance stewardship programs, and much more to raise C. diff. awareness and share successful implementations and guidelines.
This free webinar is available to you and with the ease of learning without having to travel.
The Global C. difficile Congress — eight sessions presented by topic experts – in four hours – in one day – with goals to change the C. difficile world with a common focus; To
improve awareness of C. diff. infection prevention, treatments, research, and environmental safety in the healthcare communities worldwide.
Dr. Paul Feuerstadt; Native of Long Island, New York, Dr. Feuerstadt attended the University of Pennsylvania where he earned his Bachelor of Arts degree in Biology, with distinction in research and graduated Summa Cum Laude. Following completion of his undergraduate training, Dr. Feuerstadt attended the Weill Medical College of Cornell University in Manhattan, New York where he earned his Medical Doctor degree and stayed at New York Presbyterian Hospital/Weill Cornell medical center for his internship and residency in Internal Medicine. Following completion of his residency
Dr. Feuerstadt then moved on to the Montefiore Medical Center in the Bronx, NY for his clinical fellowship training.His areas of interest include ischemic diseases of the gut and chronic diarrheal syndromes with a specific focus on C.diff. infections.Dr. Feuerstadt is affiliated with St. Raphael campus of Yale-New Haven Hospital, Yale-New Haven Hospital and
Milford Hospital seeing outpatients in his offices in Hamden and Milford, CT Topic: Welcome – Introduction
8:15 – 8:45 a.m. 1:15 – 1:45 Jean de Gunzburg, PhD
Dr. de Gunzburg is Chief Scientific Officer of Da Volterra, an emerging biotechnology company, headquartered in Paris, France. Prior to this, Jean de Gunzburg led an academic research career in molecular and cell biology at the Institut Pasteur (Paris, France), the Whitehead Institute for Biomedical Research (Cambridge, MA, USA) and the Institut Curie (Paris, France). He is the author of over 70 publications in international peer reviewed scientific journals, and continues to serve on several grant review committees. Topic: “DAV132, A Novel Product Destined To Prevent Antibiotic-Induced
Clostridium difficile Infections.”
8:45 – 9:15 1:45 – 2:15 Arjun Srinivasan, MD
Dr. Arjun Srinivasan is the Associate Director for healthcare-associated infection (HAI) prevention programs in the Division of Healthcare Quality Promotion at the Center for Disease Control and Prevention’s National Center for Emerging and Zoonotic Infectious Diseases. Dr. Srinivasan is also a captain in the US Public Health Service. An infectious disease doctor, Dr. Srinivasan oversees several CDC programs aimed at eliminating healthcare-associated infections and improving antibiotic use. For much of his CDC career, Dr. Srinivasan ran the healthcare outbreak investigation unit, helping hospitals and other healthcare facilities track down bacteria and stop them from infecting other patients. Dr. Srinivasan leads the CDC’s work to improve antibiotic prescribing and works with a team of CDC experts researching new strategies. Topic: “Antibiotic Stewardship- Improving Antibiotic Use to Combat C diff.”
9:15 – 9:45 2:15 – 2:45 Clifford McDonald, MD
Dr. McDonald graduated from Northwestern University Medical School. He completed a medical microbiology fellowship at Duke University and is a former member of CDC’s Epidemic Intelligence Service. Dr. McDonald is currently the Associate Director for Science in the Division of Healthcare Quality Promotion at the CDC. He has first authored or co-authored over 100 peer reviewed publications on subjects related to healthcare and infectious disease epidemiology Dr. McDonald joins fellow world-renowned topic experts to discuss the burden of C. difficileinfections with the risk factors pertaining to current and emerging treatment options along with the importance of applying evidence-based clinical approaches to the prevention of a C. difficile infection (CDI), one of the leading community and healthcare-associated infections. Topic: “Challenges and Opportunities Posed by Current Diagnostics
for Clostridium difficile Infection”
Barley Chironda a Nurse, National Healthcare Sales Director and Infection Control Specialist Clorox Canada, Social Media Manager of IPAC Canada, and the current President of IPAC- GTA. Mr. Chironda is certified in Infection prevention and control (CIC) and has worked extensively in Infection Control. He is typically found engaged in motivating hospital staff, patients and the public on proper infection prevention practices. Mr. Chironda’s roles allow great participation in quality improvement interventions related to patient and public safety. Therefore Barley has been an integral to the successful decline in Clostridium difficile infections through implementing innovative technology and quality improvement behavioral change. Topic: “The C.diff.. Disinfection Debate: To Use
Or Not To Use Sporicidal Disinfectants Every-Time In Healthcare Facilities.”
10:15 -10:45 3:15 – 3:45 Dale Gerding, MD
Dr. Dale Gerding, Professor of Medicine at Loyola University Chicago Stritch School of Medicine in Maywod, Illinois and Research Physician at the Edward Hines Jr. VA Hospital. Prior to his present position Dr. Gerding was Chief of Medicine at VA Chicago, Lakeside Division, and Professor of Medicine at Northwestern University Feinberg School of Medicine. He is an infectious diseases specialist and hospital epidemiologist, past president of the Society for Healthcare Epidemiology of America and past chair the antibiotic resistance committee of SHEA. He is a fellow of the Infectious Diseases Society of America and past Chair of the National and Global Public Health Committee and the Antibiotic Resistance Subcommittee of IDSA. He served as a member of the Board of Directors of IDSA from 2005-2008. He is a Master of the American College of Physicians and the 2013 recipient of the William Middleton Award, the highest research award given by the Department of Veterans Affairs. He is a member of the American Society for Microbiology, and is board certified in Internal Medicine and Infectious Diseases. His research interests include the epidemiology and prevention of Clostridium difficile disease, antimicrobial resistance, and antimicrobial distribution and kinetics. He has been a Merit Review funded research investigator in the VA for over 40 years and is the author of over 400 peer-reviewed journal publications, book chapters, and review articles. He holds patents for the use of non-toxigenic C. difficile for the prevention and treatment of this disease. Topic: “Non-toxigenic Clostridium difficile for Prevention of CDI”
10:45 – 11:15 3:45 – 4:15 Richard Vickers, PhD
Dr. Richard Vickers is the Chief Scientific Officer, Antimicrobials and Programme Lead for CDI,
Summit Therapeutics. He joined Summit in 2003 and during his time has worked in a variety of roles involved in the development and management of various antibacterial therapeutic programs. This includes leading the discovery and development of ridinilazole, the investigational antibiotic for the treatment of C. difficile infection. Prior to joining Summit, Dr Vickers undertook postdoctoral research studies with Professor Stephen Davies at the University of Oxford and held a Stipendiary Lectureship in organic chemistry at St. Catherine’s College in Oxford. Dr Vickers received a Ph.D. in organic chemistry from the University of Reading and a B.Sc. in chemistry from King’s College London. Topic: “Ridinilazole; A Selective Therapy for the Treatment
of C. difficile Infections (CDI)”
11:15 – 11:45 4:15 – 4:45 Simon Cutting, PhD
Professor Cutting of Molecular Microbiology at Royal Holloway, University of London is a bacterial geneticist with over 25 years of experience with Bacillus since graduating from Oxford University with a D. Phil in 1986. His D.Phil was on understanding the genetic control of spore formation in Bacillus Clostridium difficile.. His other expertise is in the use of Bacillus spores as probiotics and has a number of contracts and consultancies with European and US companies in the food and feed sectors. Topic: “Thwarting the Opportunist: An Anti-adhesion
Vaccine That Prevents C.difficult Colonization.”
11:45 – 12:15 4:45 – 5:15 Hudson Garrett, Jr, PhD
Dr. Garrett is currently employed as the Global Chief Clinical Officer for Pentax Medical. He holds a dual Masters in Nursing and Public Health, Post-Masters Certificate as a Family Nurse Practitioner, a Post-Masters Certificate in Infection Prevention and Infection Control and a PhD in Healthcare Administration and Policy. He has completed the Johns Hopkins Fellows Program in Hospital Epidemiology and Infection Control, and the CDC Fundamentals of Healthcare Epidemiology program, and is board certified in family practice, critical care, vascular access, moderate sedation, infection prevention, legal nurse consulting, and a director of nursing in long term care. Dr. Garrett is also a Fellow in the Academy of National Associations of Directors of Nursing Administration in Long Term Care. Topic: “Improving Patient Safety and Reducing Clostridium difficile
through Collaboration with Clinical Nursing and Environmental Services Professionals”
For more information please visit the Global C. difficile Congress
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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
Summit Therapeutics: ridinilazole, a microbiome preserving antibiotic for the treatment of a C. difficile infection (CDI)
With Our Guests:
Dr. Kevin W. Garey; Chair, Department of Pharmacy Practice and Translational Research Professor of Pharmacy Practice at the University of Houston College of Pharmacy, Houston, TX
Dr. Richard Vickers, Chief Scientific Officer at Summit Therapeutics
Join us as we discuss a promising and new treatment for a C. difficile infection. Summit Therapeutic’s Ridinilazole, a microbiome preserving antibiotic will be introduced with updates with our guests Dr. Kevin W. Garey, Chair, Department of Pharmacy Practice and Translational Research, Professor of Pharmacy Practice at the University of Houston College of Pharmacy, Houston, Texas and Dr. Richard Vickers, Chief Scientific Officer at Summit Therapeutics
“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 Head 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.
Programming for C. diff. Spores and More is made possible through our official Sponsor; Clorox Healthcare