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Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
Romark Laboratories L.C.

Study Description
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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
Clostridium Infections Drug: Nitazoxanide Drug: Vancomycin Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Clinical response (resolution of all symptoms of CDAD) [ Time Frame: End of treatment (day 12-14 after beginning treatment) ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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. ]
  3. Sustained clinical response [ Time Frame: End of treatment response sustained through study day 31. ]
  4. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Romark Laboratories L.C.
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Romark Laboratories L.C.:
Clostridium difficile
Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
 Vancomycin
Nitazoxanide
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents