Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

This study has been completed.
Sponsor:
Information provided by:
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00417872
First received: January 3, 2007
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Clostridium Difficile
Drug: Nitazoxanide
Drug: Metronidazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multicenter, Double Blind, Metronidazole Controlled, Dose Range Finding Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Resource links provided by NLM:


Further study details as provided by Romark Laboratories L.C.:

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

Estimated Enrollment: 114
Study Start Date: January 2004
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417872

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

No publications provided

ClinicalTrials.gov Identifier: NCT00417872     History of Changes
Other Study ID Numbers: RM01-2015
Study First Received: January 3, 2007
Last Updated: January 3, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Romark Laboratories L.C.:
Clostridium difficile

Additional relevant MeSH terms:
Metronidazole
Nitazoxanide
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014