Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

NCT00417872 | Completed Phase 2

• 1 other identifier: RM01-2015
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Clostridium Difficile

Keywords

Clostridium difficile

Outcome Measures

Primary Outcomes (1)

• Clinical response (resolution of all symptoms present at baseline) recorded on day 8

Secondary Outcomes (4)

• Time from first dose to passage of last unformed stool

• Time from first dose to resolution of symptoms

• Sustained clinical response (resolution of all symptoms present at baseline with no recurrence during follow-up)

• C. difficile toxin enzyme immunoassay/culture results during hospitalization

Interventions

Nitazoxanide DRUG

Metronidazole DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• In-patients with new onset of colitis evidenced by diarrhea (≥3 unformed stools within 24 hours), with one or more of the following: abdominal pain or cramps; peripheral leukocytosis, otherwise unexplained; or fever, otherwise unexplained.
• C. difficile toxin A or B detected in a stool specimen obtained within 7 days before enrollment by enzyme immunoassay.
• Patients able to take oral medications.
• Patients willing to avoid the following medications during the study: oral and intravenous metronidazole, oral vancomycin, anti-peristaltic drugs, opiates, Saccharomyces cerevisiae (baker's yeast), Lactobacillus GC, cholestyramine or colestipol. \[Patients on opiates may be included in the study as long as they were taking opiates prior to enrollment and the dose is not increased during the study\].
• Patients willing to abstain from alcohol during the 10-day treatment duration and for two days following treatment.

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).
• 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. \[Patients that have taken up to 2 doses of metronidazole or vancomycin can be included in the study\].
• Patients taking phenytoin, celecoxib, and/or losartan. \[Patients taking Coumadin® (warfarin) may be included as long the prothrombin time is monitored at least twice weekly during the first 2 weeks of the study and at least weekly thereafter\].
• Patients with severe renal or hepatic impairment.
• Patients who are clinically unstable (e.g., patients with signs of toxic megacolon or imminent perforation).
• Serious systemic disorders incompatible with the study.
• History of hypersensitivity to metronidazole.

Sponsors & Collaborators

• Romark Laboratories L.C.: lead

Study Sites (7)

Bayfront Medical Center and Edward White Hospital

St. Petersburg, Florida, 33713, United States

Location

WellStar Infectious Diseases

Marietta, Georgia, 30060, United States

Location

Remington-Davis, Inc., and Riverside Infection Consultants, Inc.

Columbus, Ohio, 43214, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

The Reading Hospital and Medical Center

West Reading, Pennsylvania, 19611, United States

Location

Houston Veterans Affairs Hospital

Houston, Texas, 77030, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

nitazoxanide; Metronidazole

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ian M Baird, M.D.

  Remington-Davis Inc., and Riverside Infection Consultants, Inc.

  PRINCIPAL INVESTIGATOR

• Herbert L DuPont, M.D.

  CHI St. Luke's Health, Texas

  PRINCIPAL INVESTIGATOR

• Arvind K Gupta, M.D.

  Lehigh Valley Hospital

  PRINCIPAL INVESTIGATOR

• Robert S Jones, D.O.

  The Reading Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

• Arnold L Lentnek, M.D.

  WellStar Infectious Diseases, Summit Surgical Specialists, and WellStar Kennestone Hospital

  PRINCIPAL INVESTIGATOR

• Daniel Musher, M.D.

  Houston Veterans Affairs Hospital

  PRINCIPAL INVESTIGATOR

• Fadi Saba, M.D.

  Bayfront Medical Center and Edward White Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 4, 2007
• Study Start: January 1, 2004
• Study Completion: September 1, 2005
• Last Updated: January 4, 2007

Record last verified: 2005-10

Locations

US (7)