NCT00314951

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 629 (actual)
• Sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Clostridium Infections
• Diarrhea

Interventions

Type	Name	Description
DRUG	Fidaxomicin	200 mg oral capsules two times daily (q12h regimen)
DRUG	Vancomycin	125 mg capsules q6hr (4 times a day)
DRUG	Matching Placebo to Fidaxomicin	Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)

Timeline

• Start date: 2006-05-02
• Primary completion: 2008-07-23
• Completion: 2008-08-21
• First posted: 2006-04-17
• Last updated: 2017-04-21
• Results posted: 2011-10-26