Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection

Completed · Phase 3

Conditions studied: Clostridium Enterocolitis, Pseudomembranous Colitis

In brief

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.

Key facts

Study ID

NCT00304356

Run by

Daniel M. Musher MD

People needed

22

Starts

2004-01-01

Expected to finish

2007-01-01

Last updated by the study team

2017-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baylor College of Medicine — Houston, Texas, United States
• Michael E. Debakey VA Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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