Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicenter, Double-blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-associated Disease
Brief Summary: 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).


Options:
A: Inclusion Criteria:

* Males and females between 18 and 90 years of age, inclusive.
* Diagnosed with primary episode or first relapse of moderate C. difficile infection.

Received ≤24 hours of therapy effective for C. difficile infection prior to enrollment.

Exclusion Criteria:

* Severe C. difficile infection
* Expected to require more than 10 days of C. difficile infection treatment.
* More than one prior episode of C. difficile infection within the prior 3 months.
* Use of anti-peristaltic drugs (including tincture of opium, metoclopramide, loperamide),, cholestyramine, or colestipol

Other protocol-defined inclusion/exclusion criteria may apply
B: Inclusion Criteria:

* Males/females with CDAD
* Females must use adequate contraception
* Signed informed consent

Exclusion Criteria:

* Life-threatening CDAD
* Toxic megacolon
* Pregnant
* Concurrent use of diarrheal agents
* Participation in other trials
C: Inclusion Criteria:

* 18 years of age and above
* The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
* Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD
* Baseline serum potassium \> 3.0 mmol (meq)/L
* Patient considered sufficiently stable clinically to likely complete 6 week study period.
D: 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.

Answer: D