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Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease

NCT00384527 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-05-05

No results posted yet for this study

Summary

The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).

Conditions

  • Clostridium Infections

Interventions

DRUG

Nitazoxanide

One nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days.

DRUG

Vancomycin

One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.

Sponsors & Collaborators

  • Romark Laboratories L.C.

    lead INDUSTRY

Principal Investigators

  • Carol Kauffman, MD · John D. Dingell VAMC

  • Adam Bressler, MD · Atlanta Institute for Medical Research

  • Wesley Bray, MD · Wellstar Clinical Trials

  • James Grendell, MD · Winthrop University Hospital

  • Bradley Allen, MD · Richard L. Roudebush VA Medical Center

  • Partha Nandi, MD · Center for Digestive Health

  • Daniel Musher, MD · Michael E. Debakey VAMC

  • Julia Garcia-Diaz, MD · Oschner Clinic Foundation

  • David Rand, MD · Torrence Memorial Hospital

  • David Johnson, MD · Bay Pines VAMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00384527 on ClinicalTrials.gov