Clinical Trial: Vancomycin vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Vancomycin Vs. Nitazoxanide to Treat Clostridium Difficile Colitis That Has Failed Therapy With Metronidazole

Brief Summary: The purpose of this study is to compare the outcome of treatment with nitazoxanide vs. vancomycin for diarrheal disease due to Clostridium difficile in patients who have failed previous treatment with metronidazole.

Detailed Summary:

Clostridium difficile is the leading cause of nosocomial diarrheal disease associated with antibiotic therapy. This is a debilitating condition with substantial morbidity and a mortality that used to be said to be around 2-3%, but that has recently been shown by us (Clin Infect. Dis, July, 2005) and others (Pepin et al, Clin. Infect. Dis., July, 2005) to be substantially higher -- approximately 15-20%. There has been an enormous increase in this disease at the VA medical center during the past two years, just as has occurred at other hospitals throughout the United States and the developed world.

Although orally administered vancomycin was the first drug to be approved in treating C. difficile colitis, and remains the only one with the official approval by the Food and Drug Administration, the currently recommended therapy for this condition is metronidazole, given orally. This drug was recommended because: (1) the cost of vancomycin was exceedingly high; (2) there was concern that vancomycin-resistant bacteria might appear in hospitals if the drug was used to treat large number of patients; and (3) these recommendations were made at a time that the cure rate from metronidazole was thought to approach 100%.

We have recently shown that 23% of patients fail to respond to initial therapy with metronidazole, and another 27% relapse after treatment (Musher et al, Clin Infect Dis, July, 2005). Others have confirmed these observations (Pepin et al, Clin Infect Dis, July 2005). The options for treating failure or relapse are limited. Another course of metronidazole may cure about one-half of patients. Oral vancomycin may be used, but this drug also has a failure rate of 10-20% and the concerns about its use remain.

Based on this background, we became interested in studying nitazoxa
Sponsor: VA Medical Center, Houston

Current Primary Outcome: Days to symptom resolution [ Time Frame: observation ]

Original Primary Outcome:

Current Secondary Outcome: side effects [ Time Frame: observational ]

Original Secondary Outcome:

Information By: VA Medical Center, Houston

Dates:
Date Received: March 16, 2006
Date Started: January 2006
Date Completion:
Last Updated: June 1, 2015
Last Verified: February 2013