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First new C. difficile drug in a generation superior to existing treatments: Researchers
Date:2/2/2011

This release is available in French.

Clostridium difficile infection (CDI) is a significant and growing problem in hospitals and other health care facilities, but no new drugs to treat the condition have been developed in several decades. However, a large-scale, phase 3 trial conducted by Canadian and U.S. researchers shows that the new antibiotic Fidaxomicin is superior to existing treatments, demonstrating a 45 percent reduction in recurrences vs. the existing licensed treatment. Their results were published in February, 2011 in The New England Journal of Medicine.

"There wasn't much interest in C. difficile for many years, because it wasn't considered a serious disease," said study co-author Dr. Mark A. Miller, head of the Division of Infectious Diseases and Chief of Microbiology at the Jewish General Hospital in Montreal, and a clinical investigator at the Lady Davis Institute for Medical Research. "However, over the past decade the bacterium has mutated into something much more serious that has caused epidemics worldwide. It is particularly notorious for recurrences. About 20 to 30 percent of patients suffer relapses. Recurrent C. difficile is very difficult to treat, and this has spurred interest in newer and better treatments."

Fidaxomicin, developed by Optimer Pharmaceuticals of San Diego, is the first in a new class of narrow-spectrum macrocyclic antibiotics. It is only minimally absorbed from the gut into the bloodstream and is specifically targeted at C. difficile in the intestine. Thus the drug acts by killing C. difficile bacteria without affecting the beneficial flora in the human gut which help stave off recurrences.

A total of 629 patients were enrolled in the multicentre, double-blind, randomized, parallel-group trial conducted between May 9, 2006, and August 21, 2008. They
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Contact: Mark Shainblum
mshainblum@jgh.mcgill.ca
514-340-8222 x6592
Jewish General Hospital
Source:Eurekalert

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