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Posts in Category: Breakthroughs

Investigational Vaccine for Prevention of Clostridium difficile (C. diff) 

Recent news release......
Posted by Amy Autry Bush Thursday, January 16, 2014 1:43:00 PM Categories: Breakthroughs

Jacksonville Center for Clinical Research Participates in Phase III Trial of Investigational Vaccine for Prevention of Clostridium difficile (C. diff)

 

Cdiffense trial to evaluate vaccine against a leading cause

of life-threatening, healthcare-associated infections worldwide

 

Jacksonville, FL  December 5, 2013 – Jacksonville Center for Clinical Research (JCCR) announced today that it is participating in a clinical study to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile (C. diff) infection (CDI). C. diff is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. While most types of healthcare-associated infections (HAIs) are declining, C. diff is emerging as a leading cause of life-threatening, HAIs worldwide. The infection poses the greatest danger for older adults in hospitals or long-term care facilities who take broad-spectrum antibiotics.[i]

JCCR joins more than 200 sites across 17 countries from around the world in the Cdiffense clinical trial, a Phase III randomized, observer-blind, placebo-controlled study. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization of more than 72 hours for a surgical procedure. People in this age group who have had at least two hospital stays, each lasting more than 72 hours, and have received systemic antibiotics in the past year are also eligible. 

“With the emergence of difficult-to-manage strains of C. diff, CDI has become more frequent, more severe and more difficult to treat in recent years, raising concerns about how to control it and prevent transmission,” explained Alpa Patel, MD of JCCR. “Vaccination could be an efficacious, cost-effective and important public-health measure to protect individuals from C. diff.”

In 2010, the U.S. Food and Drug Administration (FDA) granted fast-track designation to the investigational C. diff vaccine candidate being developed by Sanofi Pasteur. The fast-track program of the FDA is designed to facilitate the development and expedite the review of new investigational drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

For more information about the Cdiffense Phase III trial, please contact the JCCR study coordinator at (904) 730-0166, or visit www.Cdiffense.org.

 

About C. diff

Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. According to the Centers for Disease Control and Prevention (CDC), approximately 500,000 Americans are infected with C. diff,[ii] and at least 14,000 fatalities are attributed to C. diff each year.[iii] The risk of C. diff increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks.1 A main source of C. diff is infected patients who release spores into the environment that can then infect other people. When antibiotics disrupt the gut’s normal flora and a person has ingested C. diff spores, the C. diff bacteria multiply and release potent toxins that can damage a person’s intestinal lining and cause C. diff disease.[iv]

 

About Alpa Patel, MD

Dr. Alpa Patel is a Board Certified physician specializing in Internal Medicine. She has been practicing with JCCR for five years. Dr. Patel earned her degree from The University of Florida College of Medicine, Gainesville and was trained at Shands Hospital Department of Internal Medicine, Jacksonville.

 

The clinical trial facility is located at 4085 University Blvd. S., Ste. 1; Jacksonville, FL 32216 For more information, please call (904) 730-0166 or www.jaxresearch.com

 

 

[i] Centers for Disease Control and Prevention. Frequently Asked Questions about Clostridium difficile for Healthcare Providers. Centers for Disease Control and Prevention. http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_faqs_HCP.html. Last Updated March 6, 2013. Accessed May 30, 2013.

 

[ii] Rohlke F and Stollman N. Fecal microbiota transplantation in relapsing Clostridium difficile infection. Therap Adv Gastroenterol. 2012 November; 5(6): 403–420. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3491681/#bibr37-1756283X12453637. Accessed May 30, 2013.

 

[iii] Centers for Disease Control and Prevention. Clostridium difficile Infection. Centers for Disease Control and Prevention. http://www.cdc.gov/hai/organisms/cdiff/cdiff_infect.html. Last Updated March 1, 2013. Accessed May 30, 2013.

 

[iv] Delmee M and Warny M. (1995). Clostridium difficile colitis: recent therapeutical and immunologicalconsiderations. Acta Gastroenterol Belg, 58 (3-4), p. 313-317.

 

BOTULISM Vaccine Program 2013 

Volunteering in a clinical trial provides a valuable service to your community
Posted by Amy Autry Bush Monday, September 30, 2013 4:23:00 PM Categories: Breakthroughs

Botulism refers to the condition where absorption of toxin into the bloodstream produced by the bacteria, Clostridium botulinum, causes muscle paralysis starting from the head down leading to potential disability and death. The bacteria pass either through ingestion of contaminated food or drink, wound exposure, or more worrisome for the general population, through inhalation—resulting from most likely weaponized-aerosolized delivery¹.

The ability to deliver a difficult-to-treat infection on a mass scale represents a potential public health nightmare. Some of the most feared infections that could be used by terrorists are botulism, anthrax, smallpox and the plague. Part of the national preparedness strategy includes vaccinating at least those most at risk for exposure while also stockpiling enough vaccine supply for use in the event of an attack. Jacksonville Center for Clinical Research participated in the development of the updated smallpox vaccine and Dr. Jacqmein’s team at JCCR has recently been selected to help test a new vaccine for botulism.

There is currently no commercially available immunization against botulism. Equine (horse) derived antitoxin is available in limited supply for those infected with botulism, but because antitoxin doesn’t reverse any of the existing paralysis, it is important to start therapy as soon as the diagnosis is made.³ We are now recruiting volunteers between the ages of 18 to 55 to participate in a clinical trial where over 6,000 people nationwide will receive either immunization against botulism or placebo. Patients will receive the vaccine, labs and physical exams at no cost and will be provided compensation for time and travel.

Although botulism infection does not travel from person-to-person, high priority is given to protecting those whose role it is to help others—such as decision makers, firefighters, logistics personnel, teachers, medical staff, paramedics and rescue workers, public safety and law enforcement. Please call the JCCR recruiting team at (904) 730-0166 to find out more about this important program.

Resources:

  1. http://www.upmchealthsecurity.org/website/our_work/biological-threats-and-epidemics/fact_sheets/botulinum.html
  2. http://www.cdc.gov/nczved/divisions/dfbmd/diseases/botulism/
  3. Botulism Toxin as a Biological Weapon, Medical and Public Health Management. Stephen S. Arnon, MD et al. for the Working Group on Civilian Defense. JAMA, February 28, 2001—Vol 285, No. 8. 1059
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