CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 22 enrolled
Drug / intervention
Nitazoxanidedrug
Likely dose
Nitazoxanide 500 mg orally twice dailyAI-extracted
Key inclusion· 5
  • ✓Age >18 years
  • ✓Clinical diagnosis of C. difficile associated disease (new onset diarrhea, abdominal discomfort, unexplained fever, or leukocytosis)
  • ✓Positive C. difficile toxin assay in stool
  • ✓Failed or relapsed after conventional therapy with metronidazole or vancomycin
Key exclusion· 6
  • ✕Other recognized causes of diarrhea or colitis
  • ✕Pregnancy or breastfeeding
  • ✕Inadequate contraception in women of childbearing potential
  • ✕Concurrent use of coumadin, phenytoin, celecoxib, or losartan

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00304356
NCT00304356Phase 3Completed
CompareCT.gov

Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Colitis in Patients Who Have Failed Conventional Therapy

Daniel M. Musher MD·interventional·Posted Mar 17, 2006·Updated Dec 15, 2017

In Brief

A Phase 3 clinical trial evaluating Nitazoxanide for Clostridium Enterocolitis and Pseudomembranous Colitis. Completed, enrolled 22 participants across 2 sites.

Detailed Summary

The purpose of this study is for compassionate use of nitazoxanide in the treatment of diarrheal disease due to Clostridium difficile infection when the patient has failed previous treatment with metronidazole or vancomycin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Enterocolitis, Pseudomembranous Colitis
CountriesUnited States
CollaboratorsBaylor College of Medicine

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 17, 2006
Enrollment StartJan 1, 2004
Primary CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.3 years ago

Interventions

Nitazoxanidedrug

500 mg bid