A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections

  • STATUS
    Recruiting
  • days left to enroll
    16
  • participants needed
    250
  • sponsor
    University of Michigan
Updated on 9 June 2021
Investigator
Jolene Daniel
Primary Contact
University of Michigan (6.6 mi away) Contact
+1 other location

Summary

Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among patients receiving CA, fidaxomicin is superior vancomycin. While these data are encouraging, many clinicians remain unclear on how to apply these data to patient care. Additionally, patients were excluded from the trials presented to the FDA if it was expected that they would require 7 days of CA. Therefore, the clinical question still remains of how to apply these data to the real world patient who requires a long course of CA and develops CDI while on therapy. We therefore propose an open label, comparative and prospective study of fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment of CDI among patients who are receiving a long course of CA.

We hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure for patients with CDI.

Details
Condition Clostridium Difficile Infection
Treatment Vancomycin, Fidaxomicin
Clinical Study IdentifierNCT02692651
SponsorUniversity of Michigan
Last Modified on9 June 2021

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