422. Faster Time to Resolution of Diarrhea with Fidaxomicin vs. Vancomycin in Patients with Clostridium difficile Infection
Session: Poster Session: Hospital-acquired and Transplant Infections
Friday, October 30, 2009: 12:00 AM
Room: Poster Hall A
Background: A phase 3 trial of fidaxomicin (Fdx) [OPT-80] vs. vancomycin (Van) for treatment of Clostridium difficile infection (CDI) has been used to explore the differential effect of these therapies on the time to resolution of diarrhea (TTROD). Fdx was previously shown to be equivalent to Van for achieving clinical cure but superior to Van in reducing the relapse rate and achieving global cure (= cure + no relapse).
Methods: The database of the completed phase 3 Fdx/Van comparative trial was used to analyze the effect of these 2 treatments on the TTROD. Both the modified ITT (mITT) and Per Protocol (PP) study groups were analyzed. Prospectively-collected daily bowel movement diaries were the source of data.
Results: 629 patients were enrolled into the study, of whom 596 and 548 were in the mITT and PP groups, respectively. At 60 hours after start of therapy, more Fdx patients were free of diarrhea compared with Van patients (mITT: 63.1% vs. 57.6% P=0.052 and PP: 67.6% vs. 61.5% P=0.038).
Conclusions: In this trial, fewer patients had diarrhea at 60 hours after start of Fdx therapy when compared to Van. This differential effect in TTROD may result in less environmental contamination with C. difficile, less cross-transmission of CDI, and earlier discharge from hospital of CDI inpatients. The previously demonstrated superior effect of Fdx on CDI recurrence and the currently-described reduced TTROD may translate into diminished CDI morbidity and costs for patients and the healthcare system.
Y Golan, MD, Tufts Med Ctr, Montreal, QC, Canada, A Lentnek, MD, Wellstar Infect. Dis, Montreal, QC, Canada, T Louie, MD, Univ of Calgary, Montreal, QC, Canada, M Miller, MD, Jewish General Hospital, Montreal, QC, Canada, K Mullane, DO, University of Chicago, Montreal, QC, Canada, Pam Sears, PhD, Y-K Shue, PhD, Optimer Pharma Inc, Montreal, QC, Canada, Karl Weiss, MD, Hop. Maisonneuve-Rosemont, Montreal, QC, Canada and  M. A. Miller,
Optimer Pharma Inc Role(s): Investigator, Scientific Advisor (Review Panel or Advisory Committee), Received: Research Support, Consulting Fee.
K. M. Mullane,
Optimer Pharma Inc Role(s): Investigator, Received: Research Support.
K. Weiss,
Optimer Pharma Role(s): Investigator, Received: Research Support.
A. Lentnek,
Optimer Pharma Role(s): Investigator, Received: Research Support.
Y. Golan,
Optimer Pharma Role(s): Investigator, Received: Research Support.
P. Sears,
Optimer Pharma Inc Role(s): Employee, Received: Salary.
Y. Shue,
Optimer Pharma Inc Role(s): Employee, Received: Salary.
T. J. Louie,
Optimer Pharma Inc Role(s): Investigator, Received: Research Support.