Tag Archives: C diff vaccine study

Allegheny General Hospital (AGH) Enrolls Patients In a Clinical Study Of Investigational Vaccine for Prevention Of Leading Healthcare-Associated Infection; Clostridium difficile

Allegheny General Hospital (AGH), part of Allegheny Health Network, announced that it will enroll patients in a clinical study to evaluate the safety and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile infection (CDI).

Clostridium difficile (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.

Allegheny General joins more than 200 sites across 17 countries 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 24 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 Zaw Min, MD, an infectious disease specialist who is serving as principal investigator of the trial at AGH. “Vaccination could be an efficacious, cost-effective and important public health measure to protect individuals from C. diff.”

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For more information about the Cdiffense Phase III clinical trial, please contact AGH’s study coordinator at 412.359.3095 or visit www.Cdiffense.org

Utah doctor seeks patients to test vaccine to prevent C. diff. Infection (CDI)

The clinical trial being offered by Dr. Derek Muse, a medical director for Jean Brown Research  https://www.jeanbrownresearch.com/studies/c-diff-vaccine-study/

aims to test a vaccine not yet approved by the FDA that contains inactivated toxins that are produced by the bacteria, helping to cause immunity in the bloodstream.

For more information or to enroll in the C. diff vaccine study, visit www.cdiffense.org.

C. diff has been called an “urgent threat to the public,” causing an estimated half-million infections and at least 29,000 deaths in the United States in 2011, according to the U.S. Centers for Disease Control and Prevention. Rates of infection increased 400 percent from 2000 to 2007, as more dangerous strains emerged and it has become more difficult to treat.

Clostridium difficile is a bacteria found in feces. People taking antibiotics increases the risks are more prone to picking it up, transmitting it from hand to mouth, as many of a person’s protective measures are depleted during antibiotic treatment.  C. diff. infections are also community acquired.

Dr. Muse said about half of the cases of C. diff occur in people younger than 65, but those in people age 65 and older remain in the high risk category and account for 95 percent of deaths related to the infection.

Symptoms include diarrhea, fever, nausea and other abdominal issues that can lead to a perforated colon and bacteria leaking into the bloodstream.

With this vaccine, we’re trying to reduce the chances they’d come down with this potentially virulent infection,” Muse said.

People most at risk for developing the infection include anyone who takes antibiotics, which includes patients who are hospitalized for any number of reasons, as well as those who are scheduled for various surgeries.

The clinical trial being offered by Dr. Muse, a medical director for Jean Brown Research, aims to test a vaccine not yet approved by the FDA that contains inactivated toxins that are produced by the bacteria, helping to cause immunity in the bloodstream.

“Our hope is that they’d be protected for their lifetime, but we just don’t know that yet,” Muse said. “It’s something that would be evaluated by the results of the trial.”

The trial, sponsored by global pharmaceutical company SanofiPasteur, needs 15,000 enrollees across 20 countries throughout the world to reach statistical significance. The company has successfully developed vaccines for tetanus, typhoid, pertussis, rabies and more. It also manufactures the influenza vaccine most commonly used in the market today.

***  To be eligible for the clinical trial to evaluate effectiveness against C. diff, patients *must be age 50 or older
*hospitalized twice in the past year for 24 hours or more
*and/or planning to have an upcoming surgical procedure.

Dr. Muse said the study doesn’t guarantee participants will receive the active vaccination, as placebos are used to confirm the research.

“We’re trying to bring very helpful medications to the market and that requires a lot of volunteers,” he said. “In the end, we ask patients to sacrifice a little bit of their time to participate in these studies and some medications end up saving millions of lives all over the world.”

A number of vaccines come out each year, including one for meningitis that became available earlier this year. An update of the human papillomavirus vaccination, as well as one to help the elderly avoid pneumonia are also newly available.

“These things cause so much suffering,” Muse said. “Doctors want these vaccines yesterday.”

Muse blames over-prescription of antibiotics for the growing number of cases of C. diff. Antibiotics, he said, can destroy the normal bacteria in the intestine, which can result in overgrowth of toxic spores that can injure the lining of the colon and cause diarrhea, abdominal pain and bloody stool.

The key, he said, is preventing C. diff altogether.

Antibiotic Use:  “Talk with your doctor whether you really need an antibiotic or not,” Muse said. “Many upper respiratory infections don’t need antibiotic treatment. Even mild sinus infections don’t have to be treated.”

*Utilize natural remedies when treating symptoms caused by viruses and discuss over the counter medications and alternatives available with the healthcare provider.

Antibiotics, unless necessary, should be deferred or delayed until necessary

For more information or to enroll in the C. diff vaccine study, visit www.cdiffense.org.

 

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

http://www.deseretnews.com/article/865636216/Utah-doctor-seeking-patients-to-test-vaccine-to-prevent-potentially-debilitating-infection.html