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

Diarrhea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314951
• Other study ID #: 101.1.C.003
• Secondary ID: 101.1.C.003
• Status: Completed
• Phase: Phase 3
• First received: April 13, 2006
• Last updated: April 27, 2015
• Start date: May 2006
• Est. completion date: August 2008

Study information

• Verified date: September 2011
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 629
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Infections
• Diarrhea

Intervention

Drug:
• fidaxomicin
200 mg capsules q12hr (2 times a day)
• Vancomycin
125 mg capsules q6hr (4 times a day)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global Cure	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)	No
Primary	Cure Rate at End of Therapy	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)	No
Secondary	Recurrence	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	No