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Dr. Paul Mariani

Researchers seek volunteers for clinical trials of vaccine for deadly 'superbug'

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FARGO -- Researchers here are recruiting participants for clinical trials of a vaccine to prevent infections from a sometimes deadly "superbug" resistant to antibiotics.

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The trial is open to those who are 50 or older and planning an upcoming hospitalization. Those who have had at least two hospital stays and have received oral or intravenous antibiotics in the past year also are eligible.

The vaccine aims to prevent infections from bacteria called Clostridium difficile, some strains of which have become resistant to antibiotics. The bacteria infect an estimated 500,000 Americans every year, resulting in more than 14,000 deaths.

The bacteria produce toxins that inflame the intestine, causing severe diarrhea that can persist in people with weak immune systems, including the elderly. Many of the infections are acquired in hospitals or other health care settings.

Dr. Paul Mariani, an infectious disease specialist at Sanford Health, is a local director in the national clinical trial, one of the first sites in the country to test the vaccine made by Sanofi Pasteur.

Because some strains of the Clostridium difficile are resistant to antibiotics, doctors are running out of treatments, Mariani said.

"We don't have a huge armamentarium against this infection," he said, adding that three main drugs are used.

A relatively new procedure, fecal micro biotic transfer, also is available and works in 94 percent of cases, although it is not a "first line" therapy.

"It works very well," Mariani said, though the Food and Drug Administration still considers it experimental.

Clostridium difficile infections often prove stubborn and difficult to eradicate. Once it recurs, there is a 40 to 65 percent chance of further recurrence.

"It is becoming much more problematic," Mariani said, "pretty much all over the United States."

An effective vaccine that would prevent the infection from occurring, therefore, would be life-saving tool.

Those considering participating in the study are reminded that the vaccine is not yet proven.

"Because it's a study we don't know what the results are going to be," Mariani said. "That's important to know."

He also said the study is not open to those who have an infection from Clostridium difficile. The vaccine is not a treatment, but strives to prevent infection.

For more information about the vaccine, Cdiffense, people can go online to cdiffense.org. To see about enrolling in the study, call Mariani's nurse at (701) 234-2718.

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