Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
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ClinicalTrials.gov Identifier: NCT00384527 |
Recruitment Status :
Terminated
(Study was terminated early due to slow recruitment.)
First Posted : October 6, 2006
Last Update Posted : May 5, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Clostridium Infections | Drug: Nitazoxanide Drug: Vancomycin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Multicenter, Double-blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-associated Disease |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | October 2007 |

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 Name: Alinia |
Active Comparator: 2 |
Drug: Vancomycin
One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.
Other Name: VANCOCIN |
- Clinical response (resolution of all symptoms of CDAD) [ Time Frame: End of treatment (day 12-14 after beginning treatment) ]
- Time from first dose to resolution of symptoms of CDAD [ Time Frame: Any time after beginning treatment and must be sustained through end of treatment visit ]
- Microbiological Recurrence [ Time Frame: 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 [ Time Frame: End of treatment response sustained through study day 31. ]
- Clinical Recurrence [ Time Frame: Clinical response at the end of treatment with recurrent symptoms of CDAD prior to study day 31, but no C. difficile toxins detected. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- C. 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384527
United States, California | |
Torrance Memorial Hospital | |
Torrance, California, United States, 90505 | |
United States, Florida | |
Bay Pines VAMC | |
Bay Pines, Florida, United States, 33744 | |
United States, Georgia | |
Atlanta Institute for Medical Research | |
Atlanta, Georgia, United States, 30030 | |
Wellstar Clinical Trials | |
Atlanta, Georgia, United States, 30060 | |
United States, Indiana | |
Richard L. Roudebush VAMC | |
Indianapolis, Indiana, United States, 46202 | |
United States, Louisiana | |
Oschner Clinic Foundation | |
New Orleans, Louisiana, United States, 76121 | |
United States, Michigan | |
John D. Dingell VAMC | |
Ann Arbor, Michigan, United States, 48105 | |
Center for Digestive Health | |
Troy, Michigan, United States, 48098 | |
United States, New York | |
Winthrop University Hospital | |
Mineola, New York, United States, 11501 | |
United States, Texas | |
Michael E. Debakey VAMC | |
Houston, Texas, United States, 77030 |
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 |
Responsible Party: | Romark Laboratories, L.C. |
ClinicalTrials.gov Identifier: | NCT00384527 |
Other Study ID Numbers: |
RM01-3032 |
First Posted: | October 6, 2006 Key Record Dates |
Last Update Posted: | May 5, 2015 |
Last Verified: | October 2008 |
Clostridium difficile |
Clostridium Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections |
Vancomycin Nitazoxanide Anti-Bacterial Agents Anti-Infective Agents Antiparasitic Agents |