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Completed

NCT Number: NCT00314951

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

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

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Key information

Conditions

Clostridium Infections Bacterial Infections Bacterial Infections and Mycoses Diarrhea Gram-Positive Bacterial Infections Infections Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fidaxomicin

Drug

200 mg oral capsules two times daily (q12h regimen)

Other names: PAR-101, OPT-80, Dificid®

Vancomycin

Drug

125 mg capsules q6hr (4 times a day)

Matching Placebo to Fidaxomicin

Drug

Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 17, 2006
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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