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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Clostridium Infections

In brief

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).

Key facts

Study ID

NCT00384527

Run by

Romark Laboratories L.C.

People needed

50

Starts

2006-12-01

Expected to finish

2007-10-01

Last updated by the study team

2015-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Torrance Memorial Hospital — Torrance, California, United States
• Bay Pines VAMC — Bay Pines, Florida, United States
• Atlanta Institute for Medical Research — Atlanta, Georgia, United States
• Wellstar Clinical Trials — Atlanta, Georgia, United States
• Richard L. Roudebush VAMC — Indianapolis, Indiana, United States
• Oschner Clinic Foundation — New Orleans, Louisiana, United States
• John D. Dingell VAMC — Ann Arbor, Michigan, United States
• Center for Digestive Health — Troy, Michigan, United States
• Winthrop University Hospital — Mineola, New York, United States
• Michael E. Debakey VAMC — Houston, Texas, United States

Full record on ClinicalTrials.gov

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