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Status:

TERMINATED

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

Lead Sponsor:

Romark Laboratories L.C.

Conditions:

Clostridium Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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).

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2007

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00384527

Start Date

December 1 2006

End Date

October 1 2007

Last Update

May 5 2015

Active Locations (10)

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Page 1 of 3 (10 locations)

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