Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

NCT ID: NCT00417872

Last Updated: 2007-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2005-09-30

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.

Conditions

Clostridium Difficile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Nitazoxanide

Intervention Type: DRUG

Metronidazole

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Romark Laboratories L.C.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Ian M Baird, M.D.

Role: PRINCIPAL_INVESTIGATOR

Remington-Davis Inc., and Riverside Infection Consultants, Inc.

Herbert L DuPont, M.D.

Role: PRINCIPAL_INVESTIGATOR

CHI St. Luke's Health, Texas

Arvind K Gupta, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lehigh Valley Hospital

Robert S Jones, D.O.

Role: PRINCIPAL_INVESTIGATOR

The Reading Hospital and Medical Center

Arnold L Lentnek, M.D.

Role: PRINCIPAL_INVESTIGATOR

WellStar Infectious Diseases, Summit Surgical Specialists, and WellStar Kennestone Hospital

Daniel Musher, M.D.

Role: PRINCIPAL_INVESTIGATOR

Houston Veterans Affairs Hospital

Fadi Saba, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bayfront Medical Center and Edward White Hospital

Locations

Bayfront Medical Center and Edward White Hospital

St. Petersburg, Florida, United States

WellStar Infectious Diseases

Marietta, Georgia, United States

Remington-Davis, Inc., and Riverside Infection Consultants, Inc.

Columbus, Ohio, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

The Reading Hospital and Medical Center

West Reading, Pennsylvania, United States

Houston Veterans Affairs Hospital

Houston, Texas, United States

St. Luke's Episcopal Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

RM01-2015

Identifier Type: -

Identifier Source: org_study_id