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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
Sponsored by
Romark Laboratories L.C.
About
Eligibility
Locations
Outcomes
Full info

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

First Posted
January 3, 2007
Last Updated
January 3, 2007
Sponsor
Romark Laboratories L.C.
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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
No
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:
First Name & Middle Initial & Last Name & Degree
Ian M Baird, M.D.
Organizational Affiliation
Remington-Davis Inc., and Riverside Infection Consultants, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Herbert L DuPont, M.D.
Organizational Affiliation
CHI St. Luke's Health, Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arvind K Gupta, M.D.
Organizational Affiliation
Lehigh Valley Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert S Jones, D.O.
Organizational Affiliation
The Reading Hospital and Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnold L Lentnek, M.D.
Organizational Affiliation
WellStar Infectious Diseases, Summit Surgical Specialists, and WellStar Kennestone Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Musher, M.D.
Organizational Affiliation
Houston Veterans Affairs Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fadi Saba, M.D.
Organizational Affiliation
Bayfront Medical Center and Edward White Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bayfront Medical Center and Edward White Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
WellStar Infectious Diseases
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Remington-Davis, Inc., and Riverside Infection Consultants, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
The Reading Hospital and Medical Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Houston Veterans Affairs Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

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