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A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population

NCT02254967 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2024-10-31

No results posted yet for this study

Summary

The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).

Conditions

  • Clostridium Difficile

Interventions

DRUG

Fidaxomicin

oral tablets administered in an extended pulsed regimen

DRUG

Vancomycin

oral capsule

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Astellas Pharma Europe Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-06
Primary Completion
2016-03-27
Completion
2016-05-05

Countries

  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Poland
  • Portugal
  • Romania
  • Russia
  • Slovenia
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT02254967 on ClinicalTrials.gov