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

Clostridium Infections Clinical Trial

Official title:

Multicenter, Double-blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-associated Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00384527
• Other study ID #: RM01-3032
• Status: Terminated
• Phase: Phase 3
• First received: October 5, 2006
• Last updated: May 4, 2015
• Start date: December 2006
• Est. completion date: October 2007

Study information

• Verified date: October 2008
• Source: Romark Laboratories L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Infections

Intervention

Drug:
• Nitazoxanide
One nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days.
• Vancomycin
One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response (resolution of all symptoms of CDAD)		End of treatment (day 12-14 after beginning treatment)	No
Secondary	Time from first dose to resolution of symptoms of CDAD		Any time after beginning treatment and must be sustained through end of treatment visit	No
Secondary	Microbiological Recurrence		Clinical response at end of treatment visit with recurrence of symtpoms prior to study day 31 and C. difficile toxins detected in stool.	No
Secondary	Sustained clinical response		End of treatment response sustained through study day 31.	No
Secondary	Clinical Recurrence		Clinical response at the end of treatment with recurrent symptoms of CDAD prior to study day 31, but no C. difficile toxins detected.	No