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

NCT02395848 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-03-24

Study results available
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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.

Conditions

  • Clostridium Difficile Infection

Interventions

DRUG

Fidaxomicin

200mg twice daily for 10 days followed by 200mg once daily for 20 days to prevent future recurrence of CDI

Sponsors & Collaborators

Principal Investigators

  • Christine H Lee, MD · Vancouver Island Health Authority

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2021-08-30
Completion
2021-08-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02395848 on ClinicalTrials.gov