420. Age, Serum Albumin, and Leukocytosis/Fever Predict Clinical Outcomes of Clostridium difficile Infection Treated with Fidaxomicin and Vancomycin
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; formerly OPT-80) vs. vancomycin (Van) for treatment of Clostridium difficile infection (CDI) has been used to determine if certain patient factors are able to predict clinical cure (CC), recurrence (REC) and global cure (GC; total of CC+REC) rates for this disease.
Methods: The database of the phase 3 trial was analyzed for impact of patient age, albumin, and severity (WBC/fever) at time of CDI diagnosis on CC, REC, and GC rates. Fdx and Van treatment groups were combined for this Chi-Square analysis.
Results: 629 patients were enrolled into the study, of whom 596 (mITT group) were analyzed (table). There was a significant correlation or strong trend between age and albumin with all 3 outcomes, while disease severity only correlated with CC and GC but not with the REC rate.
Conclusions: In the Fdx/Van trial, advanced patient age and low albumin levels were correlated with poor outcomes for all 3 endpoints, while disease severity (leukocytosis/fever) affected CC and GC but not the REC rate. These data may be useful to create a simplified scoring system to evaluate CDI therapy and clinical outcomes.
Patient variable
(P value)
CC rate (%)REC rate (%)GC rate (%)
Age
P value
0.040.070.007
< 4096.214.582.3
41-5084.015.970.7
51-6087.315.673.6
61-7089.824.567.8
71-8084.320.666.9
> 8180.531.455.2
Albumin
P value
< 0.0010.09< 0.001
< 2576.726.256.6
26-3588.218.072.4
> 3596.816.480.9
Severity (WBC/To)
P value
0.0040.40.04
Mild (<15K and <38C)89.318.672.7
Mod (15-25K or 38-39C)79.117.665.1
Severe (>25K or >39C)70.633.347.1
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 Inc. Role(s): Investigator, Received: Research Support.
A. Lentnek,
Optimer Pharma Inc. Role(s): Investigator, Received: Research Support.
Y. Golan,
Optimer Pharma Inc. Role(s): Investigator, Received: Research Support.
P. Sears,
Optimer Pharma Role(s): Employee, Received: Salary.
Y. Shue,
Optimer Pharma Inc. Role(s): Employee, Received: Salary.
T. J. Louie,
Optimer Pharma Inc Role(s): Investigator, Scientific Advisor (Review Panel or Advisory Committee), Received: Research Support, Consulting Fee.