posted Dec 16, 2013, 9:11 AM by Jennifer Aranda
December 13, 2013
Barbara Peters Smith
Hospital and nursing home stays are jarring enough for older adults, but anyone who has acquired a case of that nasty superbug, Clostridium difficile — C. diff — will tell you that things can get a lot worse.
The infection causes diarrhea, leading to about 14,000 deaths a year, according to the Centers for Disease Control. Most at risk are older Americans who have taken antibiotics and experienced prolonged hospital stays. And those are exactly the people wanted for a clinical trial of a new vaccine, involving 15,000 subjects in Sarasota and around the world.
Some 500,000 of us already carry C. diff bacteria spores around inside us, says Sarasota surgeon Michael Swor, and under certain circumstances, “the spores release the toxin and you get the disease.”
The best defenses, he says, are handwashing and conservative antibiotic use. But with this dire infection so rampant, he’s excited about the drug being developed by Sanofi Pasteur. This vaccine, according to its maker, is designed to create an immune response that targets those toxins.
“This could be a huge benefit for public health for the future, as far as dramatically reducing what has become an unfortunately common acquired infection,” Swor says. “Most of us in the scientific world are not worried about whether it works.”
After preliminary human trials for safety, the Food and Drug Administration is fast-tracking the Phase III study. Two of three eligible volunteers will be given the new vaccine, while a third will get a placebo.
Physician Care Clinical Research in Sarasota is among the first of 100 U.S. sites to begin enrolling subjects, with Swor as the lead investigator.
If you are 50 or older and are either planning a hospital stay in the next 60 days, or you have had two hospital stays of at least three days in the past year and have taken antibiotics, you could be a candidate for the study. Those who have had C. diff in the past are not eligible. For more information, visit cdiffense.org or call 954-2355.