Clinical Trial: Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Multicenter, Double-blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-associated Disease
Brief Summary: The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).
Detailed Summary:
Sponsor: Romark Laboratories L.C.
Current Primary Outcome: Clinical response (resolution of all symptoms of CDAD) [ Time Frame: End of treatment (day 12-14 after beginning treatment) ]
Original Primary Outcome: Clinical response (resolution of all symptoms of CDAD) at end of treatment.
Current Secondary Outcome:
- Time from first dose to resolution of symptoms of CDAD [ Time Frame: Any time after beginning treatment and must be sustained through end of treatment visit ]
- Microbiological Recurrence [ Time Frame: Clinical response at end of treatment visit with recurrence of symtpoms prior to study day 31 and C. difficile toxins detected in stool. ]
- Sustained clinical response [ Time Frame: End of treatment response sustained through study day 31. ]
- Clinical Recurrence [ Time Frame: Clinical response at the end of treatment with recurrent symptoms of CDAD prior to study day 31, but no C. difficile toxins detected. ]
Original Secondary Outcome:
- Time from first dose to resolution of symptoms of CDAD
- Recurrence prior to study day 31
- Sustained clinical response at day 31
Information By: Romark Laboratories L.C.
Dates:
Date Received: October 5, 2006
Date Started: December 2006
Date Completion:
Last Updated: May 4, 2015
Last Verified: October 2008
