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J Infect Dis. 2014 May 1;209(9):1446-51. doi: 10.1093/infdis/jit598. Epub 2013 Nov 11.

Whole-genome sequencing demonstrates that fidaxomicin is superior to vancomycin for preventing reinfection and relapse of infection with Clostridium difficile.

Author information

1
NIHR Oxford Biomedical Research Centre, University of Oxford, United Kingdom.

Abstract

Whole-genome sequencing was used to determine whether the reductions in recurrence of Clostridium difficile infection observed with fidaxomicin in pivotal phase 3 trials occurred by preventing relapse of the same infection, by preventing reinfection with a new strain, or by preventing both outcomes. Paired isolates of C. difficile were available from 93 of 199 participants with recurrences (28 were treated with fidaxomicin, and 65 were treated with vancomycin). Given C. difficile evolutionary rates, paired samples ≤2 single-nucleotide variants (SNVs) apart were considered relapses, paired samples >10 SNVs apart were considered reinfection, and those 3-10 SNVs apart (or without whole-genome sequences) were considered indeterminate in a competing risks survival analysis. Fidaxomicin reduced the risk of both relapse (competing risks hazard ratio [HR], 0.40 [95% confidence interval {CI}, .25-.66]; P = .0003) and reinfection (competing risks HR, 0.33 [95% CI, 0.11-1.01]; P = .05).

KEYWORDS:

Clostridium difficile; fidaxomicin; recurrence; whole genome sequencing

PMID:
24218500
PMCID:
PMC3982846
DOI:
10.1093/infdis/jit598
[Indexed for MEDLINE]
Free PMC Article
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