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A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System

NCT01775397 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-01-13

No results posted yet for this study

Summary

The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.

Conditions

  • Clostridium Difficile

Interventions

DRUG

Fidaxomicin

capsule

DRUG

Vancomycin

capsule

DRUG

Placebo

Capsule

Sponsors & Collaborators

  • Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    collaborator INDUSTRY

  • Astellas Pharma Europe Ltd.

    lead INDUSTRY

Principal Investigators

  • Associate Director Medical Affairs · Astellas Pharma Europe Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-29
Primary Completion
2013-04-15
Completion
2013-04-15

Countries

  • Austria
  • Denmark
  • France
  • Germany
  • Greece
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT01775397 on ClinicalTrials.gov