Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection

NCT00304356 | Completed Phase 3 Results

• 1 other identifier: H-15601
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is for compassionate use of nitazoxanide in the treatment of diarrheal disease due to Clostridium difficile infection when the patient has failed previous treatment with metronidazole or vancomycin.

Conditions

Clostridium Enterocolitis; Pseudomembranous Colitis

Keywords

Clostridium difficile Associated Diarrhea

Outcome Measures

Primary Outcomes (1)

• Nitazoxanide

  stopping of diarrhea

  30 days

Study Arms (1)

active drug

OTHER

500 mg nitazoxanide bid given to patient

Drug: Nitazoxanide

Interventions

Nitazoxanide DRUG

500 mg bid

Also known as: alinia

active drug

Eligibility Criteria

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

You may qualify if:

• Patient must be \> 18 years of age
• Clinical diagnosis of C. difficile associated disease, based on the new onset of diarrhea, abdominal discomfort, or otherwise unexplained fever or leukocytosis
• Diagnosis of C. difficile colitis proven by positive assay for C. difficile toxin in feces
• Disease has been treated, and the symptoms failed to respond to treatment with metronidazole or vancomycin, or symptoms promptly relapsed after completing a course of therapy with either of these drugs
• Able to take oral medication

You may not qualify if:

• Patients with other recognized causes of diarrhea or colitis
• Women of child bearing age who are pregnant, breast feeding, or not using birth control
• Patients taking coumadin, phenytoin, celecoxib, or losartan
• Patients with renal insufficiency (BUN or creatinine \>2 times baseline)
• Serious systemic disorder incompatible with the study

Sponsors & Collaborators

• Daniel M. Musher MD: lead
• Baylor College of Medicine: collaborator

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Michael E. Debakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Enterocolitis, Pseudomembranous

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Daniel Musher
• Organization: VA Houston

daniel.musher@va.gov

713-794-7386

Study Officials

• Daniel M Musher, M.D.

  Baylor College of Medicine, Houston VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 16, 2006
• First Posted: March 17, 2006
• Study Start: January 1, 2004
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: December 15, 2017
• Results First Posted: December 15, 2017

Record last verified: 2017-05

Locations

US (2)