First new C. difficile drug in a generation superior to existing treatments: Researchers

Feb 02, 2011

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 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 received Fidaxomicin (200 mg twice daily) or the antibiotic vancomycin (125 mg four times daily) orally for 10 days. Vancomycin was first developed in the 1950s, and to date is the only FDA- and Health Canada-approved treatment for CDI.

"These results showed that recurrence of CDI is significantly less likely to occur following treatment with Fidaxomicin versus ," said lead author, Thomas J. Louie, M.D., Medical Director, Infection Prevention and Control for the Calgary Health Region and professor in the Departments of Medicine and Microbiology-Infectious Diseases, University of Calgary.

"Anybody who knows C. difficile recognizes that recurrences are the major problem with this disease," agreed Dr. Miller, also assistant professor in Medicine, Microbiology and Immunology at McGill University. "Anything that can reduce the recurrence rate, especially as dramatically as Fidaxomicin, is a very important milestone in the treatment of C. difficile."

Explore further: Ebola reveals shortcomings of African solidarity

Provided by Jewish General Hospital

not rated yet
add to favorites email to friend print save as pdf

Related Stories

C. difficile and antibiotics not necessarily linked

Oct 07, 2008

The latest study by Dr. Sandra Dial from the Research Institute of the MUHC, McGill University, and Attending Staff in the Intensive Care Unit at the Jewish General Hospital, questions the assumption held by a vast majority ...

Doctors identify patients at high risk of C. difficile

Apr 01, 2009

Doctors have developed and validated a clinical prediction rule for recurrent Clostridium difficile (C. difficile) infection that was simple, reliable and accurate, and can be used to identify high-risk patients most likely t ...

The balance shifts

May 27, 2008

The risk of contracting a Clostridium difficile infection following operations for which a "prophylactic" antibiotic is given to prevent infection is 21 times greater now than it was just a decade ago, according to researchers ...

Recommended for you

Ebola reveals shortcomings of African solidarity

8 hours ago

As Africa's leaders meet in Ethiopia to discuss the Ebola crisis, expectations of firm action will be tempered by criticism over the continent's poor record in the early stages of the epidemic.

Second bird flu case confirmed in Canada

Jan 30, 2015

The husband of a Canadian who was diagnosed earlier this week with bird flu after returning from a trip to China has also tested positive for the virus, health officials said Friday.

What exactly is coronavirus?

Jan 30, 2015

The conflicts in Syria and Iraq are straining public health systems and public health efforts meant to prevent and detect the spread of infectious diseases. This is generating a "perfect storm" of conditions for outbreaks. Among the infections raising concern is Middle East Respiratory Syndrome, caused by a type of coronavirus, which emerged in 2012. ...

Scientists find Ebola virus is mutating

Jan 30, 2015

(Medical Xpress)—Researchers working at Institut Pasteur in France have found that the Ebola virus is mutating "a lot" causing concern in the African countries where the virus has killed over eight thous ...

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.