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Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Primary Purpose

Clostridium Difficile

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Nitazoxanide

Metronidazole

About this trial

This is an interventional treatment trial for Clostridium Difficile focused on measuring Clostridium difficile

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Bayfront Medical Center and Edward White Hospital
WellStar Infectious Diseases
Remington-Davis, Inc., and Riverside Infection Consultants, Inc.
Lehigh Valley Hospital
The Reading Hospital and Medical Center
Houston Veterans Affairs Hospital
St. Luke's Episcopal Hospital

Outcomes

Primary Outcome Measures

Clinical response (resolution of all symptoms present at baseline) recorded on day 8

Secondary Outcome Measures

Time from first dose to passage of last unformed stool

Time from first dose to resolution of symptoms

Sustained clinical response (resolution of all symptoms present at baseline with no recurrence during follow-up)

C. difficile toxin enzyme immunoassay/culture results during hospitalization

Full Information

NCT ID

NCT00417872

First Posted

January 3, 2007

Last Updated

January 3, 2007

Sponsor

Romark Laboratories L.C.

1. Study Identification

Unique Protocol Identification Number

NCT00417872

Brief Title

Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2005

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Romark Laboratories L.C.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clostridium Difficile

Keywords

Clostridium difficile

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

114 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nitazoxanide

Intervention Type

Drug

Intervention Name(s)

Metronidazole

Primary Outcome Measure Information:

Title

Clinical response (resolution of all symptoms present at baseline) recorded on day 8

Secondary Outcome Measure Information:

Title

Time from first dose to passage of last unformed stool

Title

Time from first dose to resolution of symptoms

Title

Sustained clinical response (resolution of all symptoms present at baseline with no recurrence during follow-up)

Title

C. difficile toxin enzyme immunoassay/culture results during hospitalization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: