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Optimer Announces Presentation of Additional Data from Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection (CDI) Presented at ICAAC
Date:9/14/2010

Phase 3 trials and their relationship to outcome.  These data show that the cure rate among patients harboring BI isolates was significantly lower than those with non-BI strains (86.5% vs. 94.3%, p=0.0006) and that the recurrence rate was significantly higher for those with the BI strain versus the non-BI strains (27.3% vs. 16.6%, p=0.003).  In the trials, the BI strain of Clostridium difficile was the major strain type (39%) in North America but the BI strain was not nearly as frequent in Europe (10%). In the non-BI group recurrence rates were significantly lower in  patients treated with fidaxomicin versus patients treated with vancomcyin (8.4% vs. 25.3%, p<0.001).  In the BI group fidaxomicin showed a clinically meaningful 25% reduction in recurrence rates compared to vancomycin (23.3% vs 31.2%).Clinical investigator, Mark A. Miller, M.D., head of the Division of Infectious Diseases, Chair of the Infection Prevention and Control Unit at the Jewish General Hospital in Montreal, Quebec, Canada, presented analyses on a bedside scoring system for assessing CDI risk factors. There is currently no validated bedside risk assessment tool to categorize patients or predict CDI cure or recurrence. Using data from Optimer's first fidaxomicin Phase 3 trial, researchers evaluated a scoring system composed of five simple patient risk factors:  Age, Temperature (T), Leukocytosis (WBC), Albumin (Alb), and Concomitant Systemic Antibiotics (SA).  These five bedside risk factors were combined to correlate with CDI cure, recurrence, and global cure.  Dr. Miller recommended that this scoring system should be validated on other databases of CDI patients in order to assist in predicting CDI cure, recurrence, morbidity, and mortality.  

For a complete list of posters, please visit the Resources page on our website at: www.optimerpharma.com

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