Trial record 16 of 114 for:    bay pines

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

This study has been terminated.
(Study was terminated early due to slow recruitment.)
Sponsor:
Information provided by:
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00384527
First received: October 5, 2006
Last updated: October 1, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Clostridium Infections
Drug: Nitazoxanide
Drug: Vancomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Romark Laboratories L.C.:

Primary Outcome Measures:
  • Clinical response (resolution of all symptoms of CDAD) [ Time Frame: End of treatment (day 12-14 after beginning treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Sustained clinical response [ Time Frame: End of treatment response sustained through study day 31. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: October 2006
Estimated Study Completion Date: September 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384527

Locations
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
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 Department of Veterans Affairs
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

No publications provided by Romark Laboratories L.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Romark Laboratories, L.C.
ClinicalTrials.gov Identifier: NCT00384527     History of Changes
Other Study ID Numbers: RM01-3032
Study First Received: October 5, 2006
Last Updated: October 1, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Romark Laboratories L.C.:
Clostridium difficile

Additional relevant MeSH terms:
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Nitazoxanide
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 21, 2014