NCT00384527

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 5, 2015

Status Verified

October 1, 2008

Enrollment Period

10 months

First QC Date

October 5, 2006

Last Update Submit

May 4, 2015

Conditions

Clostridium Infections

Keywords

Clostridium difficile

Outcome Measures

Primary Outcomes (1)

  • Clinical response (resolution of all symptoms of CDAD)

    End of treatment (day 12-14 after beginning treatment)

Secondary Outcomes (4)

  • Time from first dose to resolution of symptoms of CDAD

    Any time after beginning treatment and must be sustained through end of treatment visit

  • Microbiological Recurrence

    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

    End of treatment response sustained through study day 31.

  • Clinical Recurrence

    Clinical response at the end of treatment with recurrent symptoms of CDAD prior to study day 31, but no C. difficile toxins detected.

Study Arms (2)

1

EXPERIMENTAL
Drug: Nitazoxanide

2

ACTIVE COMPARATOR
Drug: Vancomycin

Interventions

NitazoxanideDRUG

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

Also known as: Alinia
1
VancomycinDRUG

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

Also known as: VANCOCIN
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Torrance Memorial Hospital

Torrance, California, 90505, United States

Location

Bay Pines VAMC

Bay Pines, Florida, 33744, United States

Location

Atlanta Institute for Medical Research

Atlanta, Georgia, 30030, United States

Location

Wellstar Clinical Trials

Atlanta, Georgia, 30060, United States

Location

Richard L. Roudebush VAMC

Indianapolis, Indiana, 46202, United States

Location

Oschner Clinic Foundation

New Orleans, Louisiana, 76121, United States

Location

John D. Dingell VAMC

Ann Arbor, Michigan, 48105, United States

Location

Center for Digestive Health

Troy, Michigan, 48098, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Michael E. Debakey VAMC

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 19133801DERIVED

MeSH Terms

Conditions

Clostridium Infections

Interventions

nitazoxanideVancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 5, 2006

First Posted

October 6, 2006

Study Start

December 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 5, 2015

Record last verified: 2008-10

Locations

US(10)