Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
Study Details
Study Description
Brief Summary
The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: Nitazoxanide
One nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days.
Other Names:
|
| Active Comparator: 2
|
Drug: Vancomycin
One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Clinical response (resolution of all symptoms of CDAD) [End of treatment (day 12-14 after beginning treatment)]
Secondary Outcome Measures
- Time from first dose to resolution of symptoms of CDAD [Any time after beginning treatment and must be sustained through end of treatment visit]
- Microbiological Recurrence [Clinical response at end of treatment visit with recurrence of symtpoms prior to study day 31 and C. difficile toxins detected in stool.]
- Sustained clinical response [End of treatment response sustained through study day 31.]
- Clinical Recurrence [Clinical response at the end of treatment with recurrent symptoms of CDAD prior to study day 31, but no C. difficile toxins detected.]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥ 18 years.
-
Patients with new onset of disease evidenced by diarrhea (≥ 3 unformed stools within 24 hours), and one or more of the following symptoms of CDAD:
-
abdominal pain or cramps
-
peripheral leukocytosis
-
fever
-
- difficile toxin A or B detected in a stool specimen obtained within 3 days before enrollment by enzyme immunoassay.
-
Patients willing to avoid the following medications during the study:
-
oral and intravenous metronidazole
-
oral vancomycin
-
anti-peristaltic drugs
-
opiates (patients on opiates may be included in the study if they were taking opiates prior to enrollment and the dose is not increased during the study)
-
Saccharomyces cerevisiae (baker's yeast)
-
Lactobacillus GG
-
cholestyramine
-
colestipol
Exclusion Criteria:
-
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).
-
Patients that commonly have 3 or more stools per day and/or severe abdominal pain in the absence of CDAD.
-
Patients with severe lactose intolerance.
-
Patients with more than 1 recurrence of CDAD during the 6 months prior to enrollment.
-
Patients unable to take oral medications.
-
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 3 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 and are sexually active.
-
Patients who are either clinically unstable (e.g., fulminant disease patients with signs of toxic megacolon, imminent perforation, colectomy or death) or unlikely to live throughout the 31-day duration of the study due to underlying illness.
-
History of hypersensitivity to nitazoxanide or vancomycin or any active ingredient in the formulations.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Torrance Memorial Hospital | Torrance | California | United States | 90505 |
| 2 | Bay Pines VAMC | Bay Pines | Florida | United States | 33744 |
| 3 | Atlanta Institute for Medical Research | Atlanta | Georgia | United States | 30030 |
| 4 | Wellstar Clinical Trials | Atlanta | Georgia | United States | 30060 |
| 5 | Richard L. Roudebush VAMC | Indianapolis | Indiana | United States | 46202 |
| 6 | Oschner Clinic Foundation | New Orleans | Louisiana | United States | 76121 |
| 7 | John D. Dingell VAMC | Ann Arbor | Michigan | United States | 48105 |
| 8 | Center for Digestive Health | Troy | Michigan | United States | 48098 |
| 9 | Winthrop University Hospital | Mineola | New York | United States | 11501 |
| 10 | Michael E. Debakey VAMC | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Romark Laboratories L.C.
Investigators
- Principal Investigator: Carol Kauffman, MD, John D. Dingell VAMC
- Principal Investigator: Adam Bressler, MD, Atlanta Institute for Medical Research
- Principal Investigator: Wesley Bray, MD, Wellstar Clinical Trials
- Principal Investigator: James Grendell, MD, Winthrop University Hospital
- Principal Investigator: Bradley Allen, MD, Richard L. Roudebush VA Medical Center
- Principal Investigator: Partha Nandi, MD, Center for Digestive Health
- Principal Investigator: Daniel Musher, MD, Michael E. Debakey VAMC
- Principal Investigator: Julia Garcia-Diaz, MD, Oschner Clinic Foundation
- Principal Investigator: David Rand, MD, Torrence Memorial Hospital
- Principal Investigator: David Johnson, MD, Bay Pines VAMC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RM01-3032