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Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00304356
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Baylor College of Medicine
Information provided by (Responsible Party):
Daniel M. Musher MD, VA Medical Center, Houston

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.

Condition or disease Intervention/treatment Phase
Clostridium Enterocolitis Pseudomembranous Colitis Drug: Nitazoxanide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
active drug
500 mg nitazoxanide bid given to patient
Drug: Nitazoxanide
500 mg bid
Other Name: alinia

Primary Outcome Measures :
  1. Nitazoxanide [ Time Frame: 30 days ]
    stopping of diarrhea

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00304356

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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Michael E. Debakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Daniel M. Musher MD
Baylor College of Medicine
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Principal Investigator: Daniel M Musher, M.D. Baylor College of Medicine, Houston VA Medical Center

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Responsible Party: Daniel M. Musher MD, PI, VA Medical Center, Houston Identifier: NCT00304356     History of Changes
Other Study ID Numbers: H-15601
First Posted: March 17, 2006    Key Record Dates
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017
Last Verified: May 2017
Keywords provided by Daniel M. Musher MD, VA Medical Center, Houston:
Clostridium difficile Associated Diarrhea
Additional relevant MeSH terms:
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Enterocolitis, Pseudomembranous
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antiparasitic Agents
Anti-Infective Agents