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Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by VA Medical Center, Houston.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by:
VA Medical Center, Houston
ClinicalTrials.gov Identifier:
NCT00304356
First received: March 16, 2006
Last updated: February 8, 2007
Last verified: February 2006
  Purpose

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.


Condition Intervention Phase
Clostridium Enterocolitis
Pseudomembranous Colitis
Drug: Nitazoxanide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Colitis in Patients Who Have Failed Conventional Therapy

Resource links provided by NLM:


Further study details as provided by VA Medical Center, Houston:

Primary Outcome Measures:
  • Resolution of diarrhea

Secondary Outcome Measures:
  • Time to resolution of diarrhea
  • Recurrence rate
  • Number of stools
  • Treatment success

Estimated Enrollment: 100
Detailed Description:

Clostridium difficile is the leading cause of nosocomial diarrheal disease associated with antibiotic therapy. This is a debilitating condition with substantial morbidity and a mortality that may be around 2-3%. There has been an enormous increase in this disease at the VA Medical Center during the past two years, just as has occurred at other hospitals throughout the United States.

Currently recommended therapy for this condition is metronidazole, given orally. About 15-20% of patients fail to respond to initial therapy with metronidazole, and another 20% relapse after treatment. Relapses may be treated with another course of metronidazole; about one-half will respond to this therapy. The failures are treated with oral vancomycin, but this drug also has a failure rate of 10-20%. There is, at present, no other accepted therapy (although some articles in the literature favor vancomycin with ingested bacteria from benign species). Furthermore, there is a strong risk to the emergence of resistant bacteria when hospitalized patients are treated with oral vancomycin.

Nitazoxanide is an FDA approved drug that is marketed in the U.S. and has been widely used throughout the world to treat parasitic diseases of the gastrointestinal tract; several million children have been treated with this drug during the past decade. Nitazoxanide has been approved as an antiprotozoal agent for oral administration in pediatric patients, ages 1 through 11, with diarrhea. The drug acts by interfering with anaerobic metabolic pathways, and it has been shown to have excellent in vitro activity against C. difficile. We hypothesized that this drug was both safe and effective as an alternative in patients who have diarrheal disease caused by C. difficile. The IRB approved a double-blind protocol to compare metronidazole with nitazoxanide, and we have treated a total of 16 patients so far under this protocol.

In our IRB-approved double blind study (by design, two thirds of the subjects have been randomized to the nitazoxanide), our patients have appeared to have a good response rate -- so good, in fact, that we think that nitazoxanide may be a better drug to treat this infection than either metronidazole or vancomycin.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304356

Contacts
Contact: Nancy Logan, M.A. 713-791-1414 ext 5455 njarrar@bcm.tmc.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Daniel M Musher, M.D.         
Michael E. Debakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Daniel M Musher, M.D.         
Sub-Investigator: Herbert L Dupont, MD         
Sub-Investigator: Richard J Hamill, M.D.         
Sub-Investigator: Arthur C White, M.D.         
Sub-Investigator: Saima Aslam, M.D.         
Sub-Investigator: Maria C Rodriguez-Barradas, M.D.         
Sponsors and Collaborators
VA Medical Center, Houston
Baylor College of Medicine
Investigators
Principal Investigator: Daniel M Musher, M.D. Baylor College of Medicine, Houston VA Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00304356     History of Changes
Other Study ID Numbers: H-15601
Study First Received: March 16, 2006
Last Updated: February 8, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by VA Medical Center, Houston:
Clostridium difficile Associated Diarrhea

Additional relevant MeSH terms:
Enterocolitis, Pseudomembranous
Colitis
Enterocolitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014