Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
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).
Inclusion Criteria:

 -  Age ≥ 18 years.

 -  Patients with new onset of disease evidenced by diarrhea (≥ 3 unformed stools within
 24 hours), and one or more of the following symptoms of CDAD:

 -  abdominal pain or cramps

 -  peripheral leukocytosis

 -  fever

 -  C. difficile toxin A or B detected in a stool specimen obtained within 3 days before
 enrollment by enzyme immunoassay.

 -  Patients willing to avoid the following medications during the study:

 -  oral and intravenous metronidazole

 -  oral vancomycin

 -  anti-peristaltic drugs

 -  opiates (patients on opiates may be included in the study if they were taking
 opiates prior to enrollment and the dose is not increased during the study)

 -  Saccharomyces cerevisiae (baker's yeast)

 -  Lactobacillus GG

 -  cholestyramine

 -  colestipol

 Exclusion Criteria:

 -  Patients with other known causes of diarrhea or colitis (e.g., Shigella, Salmonella,
 Cryptosporidium parvum, Giardia lamblia, Entamoeba histolytica, inflammatory bowel
 disease, irritable bowel syndrome, advanced AIDS or chemotherapy for malignancy).

 -  Patients that commonly have 3 or more stools per day and/or severe abdominal pain in
 the absence of CDAD.

 -  Patients with severe lactose intolerance.

 -  Patients with more than 1 recurrence of CDAD during the 6 months prior to enrollment.

 -  Patients unable to take oral medications.

 -  Use within 1 week of enrollment of any drug or therapy with anti-C. difficile activity
 such as oral or intravenous metronidazole and oral vancomycin. [Patients that have
 taken up to 3 doses of metronidazole or vancomycin can be included in the study].

 -  Females of child bearing age who are either pregnant, breast-feeding or not using
 birth control and are sexually active.

 -  Patients who are either clinically unstable (e.g., fulminant disease patients with
 signs of toxic megacolon, imminent perforation, colectomy or death) or unlikely to
 live throughout the 31-day duration of the study due to underlying illness.

 -  History of hypersensitivity to nitazoxanide or vancomycin or any active ingredient in
 the formulations.