Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis
Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis
The primary objective is to demonstrate non-inferiority of nitazoxanide administered 500 mg
 b.i.d compared to metronidazole administered 250 mg q.i.d. in resolving symptoms of
 Clotridium difficile colitis after seven days of treatment. Secondary objectives are to
 provide information on the times from first dose to last unformed stool and resolution of
 symptoms of colitis, the sustained response rates for the different tratment groups and the
 effect of treatment on Clostridium difficile toxin enzyme immunoassay/culture results during
 hospitalization.
Inclusion Criteria:

 -  Age ≥ 18 years.

 -  In-patients with new onset of colitis evidenced by diarrhea (≥3 unformed stools within
 24 hours), with one or more of the following: abdominal pain or cramps; peripheral
 leukocytosis, otherwise unexplained; or fever, otherwise unexplained.

 -  C. difficile toxin A or B detected in a stool specimen obtained within 7 days before
 enrollment by enzyme immunoassay.

 -  Patients able to take oral medications.

 -  Patients willing to avoid the following medications during the study: oral and
 intravenous metronidazole, oral vancomycin, anti-peristaltic drugs, opiates,
 Saccharomyces cerevisiae (baker's yeast), Lactobacillus GC, cholestyramine or
 colestipol. [Patients on opiates may be included in the study as long as they were
 taking opiates prior to enrollment and the dose is not increased during the study].

 -  Patients willing to abstain from alcohol during the 10-day treatment duration and for
 two days following treatment.

 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.