Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Romark Laboratories L.C.
• Treatments: Nitazoxanide; Vancomycin

Criteria

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.