Clinical trialNCT00417872CompletedPhase 2Interventional

Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

SponsorRomark Laboratories L.C.Enrollment114Clostridium Difficile

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The primary objective is to demonstrate non-inferiority of nitazoxanide administered 500 mg b.i.d compared to metronidazole administered 250 mg q.i.d. in resolving symptoms of Clotridium difficile colitis after seven days of treatment. Secondary objectives are to provide information on the times from first dose to last unformed stool and resolution of symptoms of colitis, the sustained response rates for the different tratment groups and the effect of treatment on Clostridium difficile toxin enzyme immunoassay/culture results during hospitalization.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Arnold L Lentnek, M.D.
WellStar Infectious Diseases, Summit Surgical Specialists, and WellStar Kennestone Hospital
Principal Investigator
clinicaltrials.gov ↗
Arvind K Gupta, M.D.
Lehigh Valley Hospital
Principal Investigator
clinicaltrials.gov ↗
Daniel Musher, M.D.
Houston Veterans Affairs Hospital
Principal Investigator
clinicaltrials.gov ↗
Fadi Saba, M.D.
Bayfront Medical Center and Edward White Hospital
Principal Investigator
clinicaltrials.gov ↗
Herbert L DuPont, M.D.
CHI St. Luke's Health, Texas
Principal Investigator
clinicaltrials.gov ↗
Ian M Baird, M.D.
Remington-Davis Inc., and Riverside Infection Consultants, Inc.
Principal Investigator
clinicaltrials.gov ↗
Robert S Jones, D.O.
The Reading Hospital and Medical Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

7 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Bayfront Medical Center and Edward White Hospital
St. Petersburg, Florida, United States
Wellstar Infectious Diseases
Marietta, Georgia, United States
Remington-Davis, Inc., and Riverside Infection Consultants, Inc.
Columbus, Ohio, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
the Reading Hospital and Medical Center
West Reading, Pennsylvania, United States
Houston Veterans Affairs Hospital
Houston, Texas, United States
St. Luke'S Episcopal Hospital
Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Metronidazole →Nitazoxanide →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Jan 2004
Primary completion: —
Completion: 30 Sept 2005
Last update posted: 4 Jan 2007
Registered enrollment: 114
Registry id: NCT00417872

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.