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Leading Experts Call for Immediate Improvements to Control Global Hospital Infection Epidemic of Clostridium-Difficile-Associated Disease

Posted on: Monday, 2 April 2007, 12:00 CDT

Leading experts called for immediate improvements in the diagnosis and treatment of Clostridium difficile-associated disease (CDAD) to contain the spread of this serious hospital-acquired diarrhea. CDAD is increasing in incidence and severity in the United States, Canada and certain European countries, according to presentations made during a symposium at the 17th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Munich, Germany.

CDAD, the most common form of hospital-acquired diarrhea, affects more than 500,000 people in the United States1 and one out of every 1,000 patients hospitalized in Europe as of 2005.2 The increased incidence and severity of the disease, coupled with an increase in treatment failures with standard therapies3, is a growing concern among public health officials, infectious diseases physicians, gastroenterologists, microbiologists and epidemiologists.

Data from the symposium entitled, "Clostridium Difficile-Associated Disease: Underdiagnosed, Underreported, Undertreated; How to Overcome the Challenges," confirmed the emergence and spread of a new virulent epidemic strain of CDAD known as North American Phenotype 1/027 (NAP1/027).

"Today's growing CDAD epidemic is characterized by the emergence of a highly virulent and resistant strain, increases in incidence and severity of infection, increases in failed responses to existing therapies, and a growing number of recurrences following treatment. These problems all contribute to a rise in healthcare costs associated with treating CDAD," said Ed Kuijper, M.D., Ph.D., Vice President, European Society of Clinical Microbiology and Infectious Diseases, Professor of Medical Microbiology, Leiden University Medical Center and co-chair of the ECCMID symposium sponsored by Optimer Pharmaceuticals (Nasdaq:OPTR). "Increased surveillance in hospitals and healthcare facilities, along with new approaches for diagnosing and treating patients, is urgently needed to combat this rapidly emerging infectious disease."

According to a presentation by Dr. Kuijper, 13 hospitals were monitored for CDAD in the Netherlands. An average of 17 per 10,000 patients (87 patients) admitted acquired CDAD, and two patients died as a result of CDAD. Early and rapid diagnosis, strict hand hygiene with soap and water, the use of gloves and aprons, grouping patients with CDAD, effective environmental cleaning with chlorine containing disinfectants, banning the use of fluoroquinolones and restricting the use of cephalosporins, were shown to help mitigate the further spread of the disease.

Frédéric Barbut, Pharm.D, Ph.D., an Infection Control Practitioner at the Infection Control Unit at Hôpital Saint-Antoine in Paris, France, and his colleagues, in collaboration with the Institut de Veille Sanitaire and regional coordinating centers, strengthened the surveillance of CDAD and built a network of regional laboratories for C. difficile characterization to promptly detect and control CDAD outbreaks in France. These investigators also confirmed the emergence and spread of the new epidemic strain North America Phenotype 1/027 (NAP1/027) in France. A national surveillance of CDAD will be launched in France in 2007 to complete the targeted surveillance of outbreak and severe CDAD.

The emergence and spread of the hypervirulent North America Phenotype 1/027 (NAP1/027) strain of CDAD in the United States, Canada and in some European countries call for improved rapid diagnosis, including the determination of C. difficile antibiotic resistance. Elisabeth Nagy, M.D., Ph.D., DSc, Professor from The Institute of Clinical Microbiology, Faculty of Medicine at the University of Szeged in Hungary, presented how molecular typing methods help track the spread of C. difficile in hospitals and the community, including real-time PCR, which is a rapid method used to detect the gene directly from feces in symptomatic patients and asymptomatic carriers.

According to Dale N. Gerding, M.D., Professor from the Department of Medicine at Loyola University Stritch School of Medicine and Associate Chief of Staff for Research & Development, Hines VA Hospital in Illinois, United States, patients prescribed metronidazole experienced poor response to therapy and high rates of recurrence following treatment. He further presented that patients prescribed vancomycin, the only FDA approved product to treat CDAD, also experienced high rates of recurrence following treatment. New agents, such as antimicrobials and monoclonal antibodies, are under development and show promise for the treatment and prevention of CDAD. Among the promising therapies under evaluation are gastrointestinal flora-sparing antibiotics, Difimicin and Rifaximin, and a toxin binder, Tolevamer.

Finally, C. difficile results in significant economic consequences for hospitals, healthcare providers and patients, including increased costs and prolonged hospital stays. Peter G. Davey, M.D., Professor from the Health Informatics Centre at the University of Dundee in Dundee, Scotland, presented data showing that patients in the intensive care unit (ICU) who contracted CDAD stayed in ICU for 6.1 days as compared to 3 days for patients with no CDAD. ICU costs increased to $11,353 versus $6,028 for patients with no CDAD.

About The Sponsor

Optimer Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products for the treatment of serious infections. Optimer currently has two late-stage anti-infective product candidates. Difimicin (OPT-80/PAR-101) is being developed for the treatment of Clostridium difficile-associated diarrhea, the most common hospital-acquired diarrhea. Prulifloxacin (OPT-99) is an antibiotic currently in two Phase 3 trials for the treatment of travelers' diarrhea, a form of infectious diarrhea. For more Company information go to www.optimerpharma.com.

Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to Difimicin, CDAD, and the timing of Clinical Trials. Words such as "believes,""anticipates,""plans,""expects,""intend,""will,""goal" and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: the timing, progress and likelihood of success of our product research and development programs, the timing and status of our preclinical and clinical development of potential drugs and other risks detailed in Optimer's filings with the Securities and Exchange Commission.

1 Centers for Disease Control

2 "ESCMID Study Group Report: A European survey of diagnostic methods and testing protocols for Clostridium difficile", Clinical Microbiology and Infection, Vol. 9 Issue 10: 989, October 2003.

3 McDonald LC, et. al (2005). "An epidemic, toxin gene-variant strain of Clostridium difficile". N Engl J Med 353: 2433--41.

Source: Business Wire

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