Official Title: “Multicenter, Double-Blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-Associated Disease”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Nitazoxanide
• Drug: Vancomycin

Primary Measures

• Clinical response (resolution of all symptoms of CDAD) at end of treatment.

Secondary Measures

• Time from first dose to resolution of symptoms of CDAD
• Recurrence prior to study day 31
• Sustained clinical response at day 31

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Romark Laboratories L.C.

Overall Clinical Trial Officials and Contacts

Carol Kauffman, MD Principal Investigator John D. Dingell VAMC  

Overall Contact: Ron Patrizio, B.A. 813-281-3326 ron.patrizio@romark.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00384527

Study ID Number: RM01-3032

ClinicalTrials.gov Identifier: NCT00384527

Health Authority: United States: Food and Drug Administration