Vancomycin vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis (NCT00304889) | Clinical Trial Compass
CompletedNot Applicable
Vancomycin vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis
United States52 participantsStarted 2006-01
Plain-language 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 metronidazole.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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 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 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