Status:
COMPLETED
Vancomycin vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis
Lead Sponsor:
Michael E. DeBakey VA Medical Center
Collaborating Sponsors:
Baylor College of Medicine
Conditions:
Clostridium Enterocolitis
Pseudomembranous Colitis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to compare the outcome of treatment with nitazoxanide vs. vancomycin for diarrheal disease due to Clostridium difficile in patients who have failed previous treatment with...
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 used to ...
Eligibility Criteria
Inclusion
- Patients \>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 symptoms recurred after the patient has completed a course of metronidazole therapy
- 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 of known causes of diarrhea, such as inflammatory bowel disease
- patients in whom diarrhea can not be evaluated, such as those with colostomy
- patients with renal insufficiency (BUN or creatinine \>3.0 times baseline)
- patients who are medically unstable, for example in an ICU and on medications to maintain blood pressure
- patients who are regarded as unlikely to survive for 3 months
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00304889
Start Date
January 1 2006
End Date
January 1 2008
Last Update
June 3 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030