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

NCT ID: NCT00384527

Last Updated: 2015-05-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2007-10-31

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).

Conditions

Clostridium Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

Nitazoxanide

Intervention Type: DRUG

One nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days.

2

Group Type: ACTIVE_COMPARATOR

Vancomycin

Intervention Type: DRUG

One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.

Interventions

Nitazoxanide

One nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days.

Intervention Type: DRUG

Vancomycin

One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.

Intervention Type: DRUG

Other Intervention Names

Alinia; VANCOCIN

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Romark Laboratories L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Romark Laboratories, L.C.

Principal Investigators

Carol Kauffman, MD

Role: PRINCIPAL_INVESTIGATOR

John D. Dingell VAMC

Adam Bressler, MD

Role: PRINCIPAL_INVESTIGATOR

Atlanta Institute for Medical Research

Wesley Bray, MD

Role: PRINCIPAL_INVESTIGATOR

Wellstar Clinical Trials

James Grendell, MD

Role: PRINCIPAL_INVESTIGATOR

Winthrop University Hospital

Bradley Allen, MD

Role: PRINCIPAL_INVESTIGATOR

Richard L. Roudebush VA Medical Center

Partha Nandi, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Digestive Health

Daniel Musher, MD

Role: PRINCIPAL_INVESTIGATOR

Michael E. Debakey VAMC

Julia Garcia-Diaz, MD

Role: PRINCIPAL_INVESTIGATOR

Oschner Clinic Foundation

David Rand, MD

Role: PRINCIPAL_INVESTIGATOR

Torrence Memorial Hospital

David Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Bay Pines VAMC

Locations

Torrance Memorial Hospital

Torrance, California, United States

Bay Pines VAMC

Bay Pines, Florida, United States

Atlanta Institute for Medical Research

Atlanta, Georgia, United States

Wellstar Clinical Trials

Atlanta, Georgia, United States

Richard L. Roudebush VAMC

Indianapolis, Indiana, United States

Oschner Clinic Foundation

New Orleans, Louisiana, United States

John D. Dingell VAMC

Ann Arbor, Michigan, United States

Center for Digestive Health

Troy, Michigan, United States

Winthrop University Hospital

Mineola, New York, United States

Michael E. Debakey VAMC

Houston, Texas, United States

Countries

United States

References

Musher DM, Logan N, Bressler AM, Johnson DP, Rossignol JF. Nitazoxanide versus vancomycin in Clostridium difficile infection: a randomized, double-blind study. Clin Infect Dis. 2009 Feb 15;48(4):e41-6. doi: 10.1086/596552.

Reference Type: DERIVED

PMID: 19133801 (View on PubMed)

Other Identifiers

RM01-3032

Identifier Type: -

Identifier Source: org_study_id