A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections
Status:
Completed
Trial end date:
2021-06-23
Target enrollment:
Participant gender:
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.