Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Clostridium Difficile Clinical Trial

Official title:

Multicenter, Double Blind, Metronidazole Controlled, Dose Range Finding Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417872
• Other study ID #: RM01-2015
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2007
• Last updated: January 3, 2007
• Start date: January 2004
• Est. completion date: September 2005

Study information

• Verified date: October 2005
• 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 is to demonstrate non-inferiority of nitazoxanide administered 500 mg b.i.d compared to metronidazole administered 250 mg q.i.d. in resolving symptoms of Clotridium difficile colitis after seven days of treatment. Secondary objectives are to provide information on the times from first dose to last unformed stool and resolution of symptoms of colitis, the sustained response rates for the different tratment groups and the effect of treatment on Clostridium difficile toxin enzyme immunoassay/culture results during hospitalization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• In-patients with new onset of colitis evidenced by diarrhea (=3 unformed stools within 24 hours), with one or more of the following: abdominal pain or cramps; peripheral leukocytosis, otherwise unexplained; or fever, otherwise unexplained.

• C. difficile toxin A or B detected in a stool specimen obtained within 7 days before enrollment by enzyme immunoassay.

• Patients able to take oral medications.

• Patients willing to avoid the following medications during the study: oral and intravenous metronidazole, oral vancomycin, anti-peristaltic drugs, opiates, Saccharomyces cerevisiae (baker’s yeast), Lactobacillus GC, cholestyramine or colestipol. [Patients on opiates may be included in the study as long as they were taking opiates prior to enrollment and the dose is not increased during the study].

• Patients willing to abstain from alcohol during the 10-day treatment duration and for two days following treatment.

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).

• 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 2 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. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an IUD, or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. In addition, female patients of child-bearing potential should have a baseline pregnancy test and should agree to continue an acceptable method of birth control for the duration of the study (including follow-up).

• Patients taking phenytoin, celecoxib, and/or losartan. [Patients taking Coumadin® (warfarin) may be included as long the prothrombin time is monitored at least twice weekly during the first 2 weeks of the study and at least weekly thereafter].

• Patients with severe renal or hepatic impairment.

• Patients who are clinically unstable (e.g., patients with signs of toxic megacolon or imminent perforation).

• Serious systemic disorders incompatible with the study.

• History of hypersensitivity to metronidazole.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile

Intervention

Drug:
• Nitazoxanide

• Metronidazole

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Remington-Davis, Inc., and Riverside Infection Consultants, Inc.	Columbus	Ohio
United States	Houston Veterans Affairs Hospital	Houston	Texas
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	WellStar Infectious Diseases	Marietta	Georgia
United States	Bayfront Medical Center and Edward White Hospital	St. Petersburg	Florida
United States	The Reading Hospital and Medical Center	West Reading	Pennsylvania

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 present at baseline) recorded on day 8
Secondary	Time from first dose to passage of last unformed stool
Secondary	Time from first dose to resolution of symptoms
Secondary	Sustained clinical response (resolution of all symptoms present at baseline with no recurrence during follow-up)
Secondary	C. difficile toxin enzyme immunoassay/culture results during hospitalization