PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)

Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)535 enrolled

Overview

This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

The primary objective of this pivotal study is to investigate the safety and efficacy of PAR-101/OPT-80 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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

535

Conditions

Clostridium Infections Diarrhea

Interventions

PAR-101/OPT-80DRUG

capsules

VancomycinDRUG

Capsules

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (116)

Outcomes

Primary Outcomes

Cure Rate at End of Therapy

Percentage of subjects 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.

Time frame: Study day 10 (+/- 2 days)

Secondary Outcomes

Recurrence

Percentage of subjects 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.

Time frame: Study days 11-40

Global Cure

Achieving a cure response at end of treatment and not having a recurrence at any time up to the post-study visit.

Time frame: End of Study

Data from ClinicalTrials.gov

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Gadsden, Alabama, United States

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Phoenix, Arizona, United States

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Hot Springs, Arkansas, United States

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La Mesa, California, United States

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Modesto, California, United States

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Palm Springs, California, United States

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Rancho Mirage, California, United States

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San Jose, California, United States

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Santa Ana, California, United States

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Vallejo, California, United States

...and 106 more locations