Whole-Genome Sequencing Demonstrates That Fidaxomicin Is Superior to Vancomycin for Preventing Reinfection and Relapse of Infection With Clostridium difficile

December 8, 2014 at 5:41 pm

Journal of Infectious Diseases May 1, 2014 V.209 N.9 P.1446-1451

BRIEF REPORT

David W. Eyre1, Farah Babakhani2, David Griffiths1, Jaime Seddon2, Carlos Del Ojo Elias1, Sherwood L. Gorbach2, Tim E. A. Peto1, Derrick W. Crook1 and A. Sarah Walker1

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

2Optimer Pharmaceuticals, San Diego, California

Correspondence: David Eyre, BMBCh, MA, DPhil, Oxford Biomedical Research Centre, Level 7 Microbiology, John Radcliffe Hospital, Oxford, OX3 9DU, United Kingdom (david.eyre@ndm.ox.ac.uk).

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).

PDF

http://jid.oxfordjournals.org/content/209/9/1446.full.pdf+html

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Entry filed under: Antimicrobianos, Bacterias, Epidemiología, Health Care-Associated Infections, Infecciones gastrointestinales, Infecciones nosocomiales, Metodos diagnosticos, REPORTS.

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