Vancomycin vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis

Completed

Conditions studied: Clostridium Enterocolitis, Pseudomembranous Colitis, Antibiotic-Associated Colitis

In brief

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.

Key facts

Study ID: NCT00304889
Run by: Michael E. DeBakey VA Medical Center
People needed: 52
Starts: 2006-01-01
Expected to finish: 2008-01-01
Last updated by the study team: 2015-06-03

Who can join

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

You may qualify if…

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

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 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

Where it is running

Michael E. DeBakey Veterans Affairs Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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