Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

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).
• •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. \[Patients that have taken up to 2 doses of metronidazole or vancomycin can be included in the study\].
• •Females of child bearing age who are either pregnant, breast-feeding or not using birth control. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an IUD, or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. In addition, female patients of child-bearing potential should have a baseline pregnancy test and should agree to continue an acceptable method of birth control for the duration of the study (including follow-up).
• •Patients taking phenytoin, celecoxib, and/or losartan. \[Patients taking Coumadin® (warfarin) may be included as long the prothrombin time is monitored at least twice weekly during the first 2 weeks of the study and at least weekly thereafter\].
• •Patients with severe renal or hepatic impairment.
• •Patients who are clinically unstable (e.g., patients with signs of toxic megacolon or imminent perforation).
• •Serious systemic disorders incompatible with the study.
• •History of hypersensitivity to metronidazole.