drugset / Trial / NCT02395848

Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection

NCT02395848

Phase 3 Terminated 31 enrolled McMaster University
NaSingle-groupOpen-labelTreatment

Summary

This is a medical research study designed to look at the safety and efficacy of 30-day course of fidaxomicin for treatment of recurrent CDI (Clostridium difficile Infection). CDI is an infection that results when the normal flora (resident bacteria) of the colon is substantially altered by antibiotic treatment. The decrease in this normal flora allows for the growth of the C. difficile bacteria. Fidaxomicin is an antibiotic which is approved by Health Canada for treatment of CDI. Only patients with a primary case of CDI or 1st episode of recurrent CDI have been studied using a 10-day course of fidaxomicin.

Timeline

Start
2015-07
Primary completion
2021-08-30
Completion
2021-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Fidaxomicin Other / unclassified 200 mg