Status:
COMPLETED
Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection
Lead Sponsor:
Daniel M. Musher MD
Collaborating Sponsors:
Baylor College of Medicine
Conditions:
Clostridium Enterocolitis
Pseudomembranous Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 metr...
Detailed Description
Clostridium difficile is the leading cause of nosocomial diarrheal disease associated with antibiotic therapy. This is a debilitating condition with substantial morbidity and a mortality that may be a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00304356
Start Date
January 1 2004
End Date
January 1 2007
Last Update
December 15 2017
Active Locations (2)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030
2
Michael E. Debakey VA Medical Center
Houston, Texas, United States, 77030