870. Factors Influencing Time to Resolution of Diarrhea (TTROD) in Patients with Clostridium difficile Infection (CDI) Treated with Fidaxomicin (FDX) or Vancomycin (VAN)
Session: Oral Abstract Session: Antimicrobial Resistance and Susceptibility
Saturday, October 22, 2011: 10:15 AM
Room: 151AB
Background: TTROD, an important endpoint for patients, varies considerably among CDI patients even when treated with effective antibiotics. We sought to identify factors that influenced TTROD in a database of 1105 patients enrolled in two phase 3 studies and treated with FDX or VAN.

 Methods:Patients with CDI confirmed by positive stool toxin test were randomized to receive oral FDX (200 mg twice daily) or oral VAN (125 mg 4 times daily) for 10 days. TTROD was determined in hours from first dose of study drug to the time of last unformed bowel movement.  Survival functions were estimated by the Kaplan-Meier product-limit method with log-rank and Wilcoxon tests to test equality across strata for each parameter at α=0.05.

Results: Diarrhea resolved 24 h later in patients infected with the REA type BI strain (median TTROD 78 h; [95% CI [61, 103]) than non-BI strains (54 h, 95% CI [51, 57]); Kaplan-Meier analysis confirmed the difference (log-rank p<0.001). Other factors associated with a significant increase in median TTROD (>24 h difference and log-rank P<0.01) were serum albumin <2.5 mg/dL (+67 h), serum creatinine ≥1.5 mg/dL (+40 h), severe renal impairment (GFR <30 mL/min; +50 h), and concurrent antibiotics used for other infections (+53 h). There was an age-dependent increase in TTROD: <40 y (baseline), 41-70 y (+7 h), and >70 y (+22 h) (log-rank P=0.001). Resolution of diarrhea was achieved by 10 d in 90% of FDX-treated and 87% of VAN-treated patients. Although the median TTROD was 9 h shorter with FDX (55h, 95% CI [51, 60]) than with VAN (64 h; 95% CI [55, 77]), the difference was not significant by Kaplan-Meier analysis.Conclusion: Renal impairment, hypoalbuminemia, concurrent antibiotics, patient age, and BI strain were all associated with increased duration of diarrhea in patients treated for CDI with FDX or VAN.

Conclusion: Renal impairment, hypoalbuminemia, concurrent antibiotics, patient age, and BI strain were all associated with increased duration of diarrhea in patients treated for CDI with FDX or VAN.


Subject Category: A. Antimicrobial agents and Resistance

Derrick Crook, MB BCh1, Mark Miller, MD, MSc2, Thomas Louie, M D3, Oliver Cornely, MD, FIDSA4, Tim Peto, MB BS, DPhil1, Dale Gerding, MD, FIDSA5 and Sherwood Gorbach, MD, FIDSA6, (1)NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom, (2)Infectious Diseases and Microbiology, McGill University, Montreal, QC, Canada, (3)University of Calgary, Calgary, AB, Canada, (4)Universität Köln, Cologne, Germany, (5)Hines Veterans Affairs Hospital and Loyola University Stritch School of Medicine, Hines, IL, (6)Tufts University School of Medicine, Boston, MA

Disclosures:

D. Crook, Optimer: Investigator, Research grant

M. Miller, Optimer: Consultant, Grant recipient

T. Louie, Ondine Biomedical Inc: Collaborator,

O. Cornely, Optimer: Investigator, Research support

T. Peto, Optimer: Scientific Advisor, Consulting fee

D. Gerding, Optimer: Investigator and Scientific Advisor, Consulting fee and Research support
ViroPharma: Consultant, Patents licensed to ViroPharma and Research Contractor, Consulting fee and Research grant
Merck: Investigator and Scientific Advisor, Consulting fee and Grant recipient
Pfizer: Scientific Advisor, Consulting fee
GOJO: Research Contractor, Research grant
TheraDoc: Scientific Advisor, Consulting fee
Actelion: Research Contractor and Scientific Advisor, Consulting fee and Research grant
Cubist: Consultant and Research Contractor, Consulting fee and Research grant
Astellas: Consultant, Consulting fee
Sanofi Pasteur: Research Contractor, Grant recipient

S. Gorbach, Optimer: Board Member, Salary

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