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Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

NCT00417872 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2007-01-04

No results posted yet for this study

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

Interventions

DRUG

Nitazoxanide

DRUG

Metronidazole

Sponsors & Collaborators

  • Romark Laboratories L.C.

    lead INDUSTRY

Principal Investigators

  • Ian M Baird, M.D. · Remington-Davis Inc., and Riverside Infection Consultants, Inc.

  • Herbert L DuPont, M.D. · CHI St. Luke's Health, Texas

  • Arvind K Gupta, M.D. · Lehigh Valley Hospital

  • Robert S Jones, D.O. · The Reading Hospital and Medical Center

  • Arnold L Lentnek, M.D. · WellStar Infectious Diseases, Summit Surgical Specialists, and WellStar Kennestone Hospital

  • Daniel Musher, M.D. · Houston Veterans Affairs Hospital

  • Fadi Saba, M.D. · Bayfront Medical Center and Edward White Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Completion
2005-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00417872 on ClinicalTrials.gov