Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Phase 3 N=27 Treatment

Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection

Clostridium Enterocolitis · Pseudomembranous Colitis

Bottom Line

View on ClinicalTrials.gov: NCT00304356 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Nitazoxanide — 27 participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Nitazoxanide (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Daniel M. Musher MD
Primary completion
Jan 2007

Outcome Measures

OutcomeResultp-value
PRIMARY
Nitazoxanide		 27 —

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.

Eligibility Criteria

Inclusion Criteria

  • Patient must be > 18 years of age
  • Clinical diagnosis of C. difficile associated disease, based on the new onset of diarrhea, abdominal discomfort, or otherwise unexplained fever or leukocytosis
  • Diagnosis of C. difficile colitis proven by positive assay for C. difficile toxin in feces
  • Disease has been treated, and the symptoms failed to respond to treatment with metronidazole or vancomycin, or symptoms promptly relapsed after completing a course of therapy with either of these drugs
  • Able to take oral medication

Exclusion Criteria

  • Patients with other recognized causes of diarrhea or colitis
  • Women of child bearing age who are pregnant, breast feeding, or not using birth control
  • Patients taking coumadin, phenytoin, celecoxib, or losartan
  • Patients with renal insufficiency (BUN or creatinine >2 times baseline)
  • Serious systemic disorder incompatible with the study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00304356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search