Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018)

March 23, 2017 updated by: Optimer Pharmaceuticals LLC

A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR-101 Taken q12h With 125 mg Vancomycin Taken q6h for Ten Days in Subjects With Clostridium Difficile-Associated Diarrhea

This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this pivotal study is to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared.

Study Type

Interventional

Enrollment (Actual)

629

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males/females with CDAD
  • Females must use adequate contraception
  • Signed informed consent

Exclusion Criteria:

  • Life-threatening CDAD
  • Toxic megacolon
  • Pregnant
  • Concurrent use of diarrheal agents
  • Participation in other trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fidaxomicin
Participants receiving fidaxomicin 200 mg capsules orally two times daily (every 12 hours [q12h] regimen) with intermittent matching placebo to fidaxomicin
Drug: Fidaxomicin
200 mg oral capsules two times daily (q12h regimen)
Other Names:
  • PAR-101
  • OPT-80
  • Dificid®
Drug: Matching Placebo to Fidaxomicin
Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)
Active Comparator: Vancomycin
Participants receiving vancomycin 125 mg capsules orally four times daily (every 6 hours [q6h] regimen).
Drug: Vancomycin
125 mg capsules q6hr (4 times a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure Rate at End of Therapy
Time Frame: Study day 10 (+/- 2 days)
Percentage of participants with 3 or fewer unformed stools for 2 consecutive days and maintained through the end of therapy, and the subject no longer needed specific anti-Clostridium antibacterial treatment after completion of the course of study medication.
Study day 10 (+/- 2 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: Study days 11-40
Percentage of participants with the re-establishment of diarrhea to an extent(based on frequency of passed unformed stools) that was greater than that noted on the last day of study medication, and the demonstration of either toxin A or B or both of C. difficile, and retreatment with CDI anti-infective therapy was needed.
Study days 11-40

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Cure
Time Frame: End of Study (Day 40)
Percentage of participants who were cured (3 or fewer unformed stools for 2 days through the end of therapy, and no C. difficile therapy after study drug completion) and didn't have recurrence (re-establishment of diarrhea that was greater than on the last day of study drug, positive C. difficile toxin and retreatment with C. difficile therapy) up to Day 40.
End of Study (Day 40)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optimer Pharmaceuticals LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2006

Primary Completion (Actual)

July 23, 2008

Study Completion (Actual)

August 21, 2008

Study Registration Dates

First Submitted

April 13, 2006

First Submitted That Met QC Criteria

April 13, 2006

First Posted (Estimate)

April 17, 2006

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5119-018
  • 101.1.C.003 (Other Identifier: Optimerpharma Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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