Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel M. Musher MD; VA Medical Center, Houston
• Collaborator: Baylor College of Medicine
• Treatments: Nitazoxanide

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