Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

January 3, 2007 updated by: Romark Laboratories L.C.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • St. Petersburg, Florida, United States, 33713
        • Bayfront Medical Center and Edward White Hospital
    • Georgia
      • Marietta, Georgia, United States, 30060
        • WellStar Infectious Diseases
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Remington-Davis, Inc., and Riverside Infection Consultants, Inc.
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
      • West Reading, Pennsylvania, United States, 19611
        • The Reading Hospital and Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • St. Luke's Episcopal Hospital
      • Houston, Texas, United States, 77030
        • Houston Veterans Affairs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Romark Laboratories L.C.

Investigators

  • Principal Investigator: Ian M Baird, M.D., Remington-Davis Inc., and Riverside Infection Consultants, Inc.
  • Principal Investigator: Herbert L DuPont, M.D., CHI St. Luke's Health, Texas
  • Principal Investigator: Arvind K Gupta, M.D., Lehigh Valley Hospital
  • Principal Investigator: Robert S Jones, D.O., The Reading Hospital and Medical Center
  • Principal Investigator: Arnold L Lentnek, M.D., WellStar Infectious Diseases, Summit Surgical Specialists, and WellStar Kennestone Hospital
  • Principal Investigator: Daniel Musher, M.D., Houston Veterans Affairs Hospital
  • Principal Investigator: Fadi Saba, M.D., Bayfront Medical Center and Edward White Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 3, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Estimate)

January 4, 2007

Last Update Submitted That Met QC Criteria

January 3, 2007

Last Verified

October 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM01-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Clostridium Difficile

Clinical Trials on Metronidazole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe