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Forschung
19.03.12 10:30
Von: Dr. Patrick Honecker

Success in the treatment of potentially fatal Clostridium difficile infection

Infection with Clostridium difficile (CDI) occurs after use of broad-spectrum antibiotics and is one of the most common infections in European hospitals today

In a current study, published in The Lancet Infectious Diseases, a research team led by Principal Investigator Prof. Oliver A. Cornely, Senior Physician in the Department of Inner Medicine I at the University Hospital of Cologne and Head of the Translational Research Platform of the Cluster of Excellence CECAD at the University of Cologne, presents evidence that the antibiotic Fidaxomicin surpasses the current standard treatment in achieving lasting control of infection. Tolerance levels are as good as those for the commonly used antibiotic Vancomycin.

“In this study we show that a sustained reduction in the decisive risk of recurrence of infection can be achieved, making Fidamocin a viable alternative treatment,“ explains Principal Investigator Prof. Oliver A. Cornely.

Infection with Clostridium difficile (CDI) frequently follows ingestion of broad-spectrum antibiotics and is one of the most common infections occurring in European hospitals today. The gut flora is harmed by ingestion of broad-spectrum antibiotics, upsetting the balance between Clostridium difficile (CD) and other bacteria.

This leads to an infestation of the inner lining of the gut with CD bacteria, causing severe diarrhea. In extreme cases a section of the gut may need to be removed or the infection can be fatal. With standard treatments the infection recurs within 30 days in 25% of cases. The European Society for Clinical Microbiology and Infectious Diseases (ESCMID) has pinpointed recurrence of infection as a key problem in the treatment of CDI. Patients over the age of 65 are particularly liable to CD infection and recurring relapse. Apart from the effects on the health of patients, this presents a significant economic burden to health services: Patients with a CD infection remain about 3.6 days longer in hospital, raising treatment costs by 54% in comparison to patients with no CD infection.

The study was performed as a double-blind procedure, meaning that neither the patient nor the attending physician knew which of the two medications was being administered. This excluded any skewing of the results through expectation of a certain outcome.  Assignment to groups within the trial was randomized. A total of 509 adults infected with CDI from seven European countries, the USA and Canada received tablets of either Fidaxomicin (2x200 mg/Day) or Vancomycin (4x125 mg/day) over a period of 10 days. A cure was achieved with both treatments in about 90% patients. The key difference lay in relapse of infection: While 27% of the patients treated with Vancomycin experienced a recurrence of infection with 30 days, only 13% of those receiving Fidaxomicin had a relapse.  The gut was cleared of infection with no recurrence within 30 days using Fidaxomicin in 77% and with Vancomycin in 63% of patients.

For the Cluster of Excellence CECAD at the University of Cologne, the success of this study underlines the importance of linking basic and clinical research into aging-associated diseases.  The main purpose of the CECAD’s Translational Platform is the systematic application of findings from basic research to clinical practice – “from bench to bedside and back”.

Fidaxomicin has been approved in the USA since May 2011 and in Europe since December 2011 for the treatment of adults with CDI.

Please address any queries to:

Prof. Oliver Cornely
Department of Inner Medicine I
University Hospital of Cologne
Center for Clinical Studies – BMBF 01KN1106
CECAD Cluster of Excellence
Telephone:  0221 478-88794
E-Mail: oliver.cornely(at)zks-koeln.de



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