Status:
COMPLETED
Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis
Lead Sponsor:
Romark Laboratories L.C.
Conditions:
Clostridium Difficile
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective is to demonstrate non-inferiority of nitazoxanide administered 500 mg b.i.d compared to metronidazole administered 250 mg q.i.d. in resolving symptoms of Clotridium difficile col...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- In-patients with new onset of colitis evidenced by diarrhea (≥3 unformed stools within 24 hours), with one or more of the following: abdominal pain or cramps; peripheral leukocytosis, otherwise unexplained; or fever, otherwise unexplained.
- C. difficile toxin A or B detected in a stool specimen obtained within 7 days before enrollment by enzyme immunoassay.
- Patients able to take oral medications.
- Patients willing to avoid the following medications during the study: oral and intravenous metronidazole, oral vancomycin, anti-peristaltic drugs, opiates, Saccharomyces cerevisiae (baker's yeast), Lactobacillus GC, cholestyramine or colestipol. \[Patients on opiates may be included in the study as long as they were taking opiates prior to enrollment and the dose is not increased during the study\].
- Patients willing to abstain from alcohol during the 10-day treatment duration and for two days following treatment.
Exclusion
- Patients with other known causes of diarrhea or colitis (e.g., Shigella, Salmonella, Cryptosporidium parvum, Giardia lamblia, Entamoeba histolytica, inflammatory bowel disease, irritable bowel syndrome, advanced AIDS or chemotherapy for malignancy).
- Use within 1 week of enrollment of any drug or therapy with anti-C. difficile activity such as oral or intravenous metronidazole and oral vancomycin. \[Patients that have taken up to 2 doses of metronidazole or vancomycin can be included in the study\].
- Females of child bearing age who are either pregnant, breast-feeding or not using birth control. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an IUD, or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. In addition, female patients of child-bearing potential should have a baseline pregnancy test and should agree to continue an acceptable method of birth control for the duration of the study (including follow-up).
- Patients taking phenytoin, celecoxib, and/or losartan. \[Patients taking Coumadin® (warfarin) may be included as long the prothrombin time is monitored at least twice weekly during the first 2 weeks of the study and at least weekly thereafter\].
- Patients with severe renal or hepatic impairment.
- Patients who are clinically unstable (e.g., patients with signs of toxic megacolon or imminent perforation).
- Serious systemic disorders incompatible with the study.
- History of hypersensitivity to metronidazole.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00417872
Start Date
January 1 2004
End Date
September 1 2005
Last Update
January 4 2007
Active Locations (7)
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1
Bayfront Medical Center and Edward White Hospital
St. Petersburg, Florida, United States, 33713
2
WellStar Infectious Diseases
Marietta, Georgia, United States, 30060
3
Remington-Davis, Inc., and Riverside Infection Consultants, Inc.
Columbus, Ohio, United States, 43214
4
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103