Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
Multicenter, Double-blind Study of Nitazoxanide Compared to Vancomycin 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).
One nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days.
One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.
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.