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Response of Clostridium Difficile Infection to Metronidazole Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00304369
First Posted: March 17, 2006
Last Update Posted: February 18, 2013
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.
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Daniel M. Musher MD, VA Medical Center, Houston
  Purpose
In this record review study, our objective is to determine the rates of cure, failure and relapse following treatment of C. difficile colitis with metronidazole.

Condition Intervention
Clostridium Enterocolitis Pseudomembranous Colitis Antibiotic-Associated Colitis Drug: Metronidazole

Study Type: Observational
Official Title: The Response of Clostridium Difficile Infection to Metronidazole Therapy

Resource links provided by NLM:


Further study details as provided by Daniel M. Musher MD, VA Medical Center, Houston:

Estimated Enrollment: 290
Study Start Date: June 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Clostridium difficile is a major cause of nosocomial infection. When this organism proliferates in the colon, usually as a result of prior antibiotic therapy in a hospitalized or otherwise debilitated person, a variety of potentially serious consequences follow, such as fever, leukocytosis, abdominal pain, diarrhea and ileus. Some patients require surgical exploration and colectomy, and our hospital has had several deaths attributable to C. difficile colitis in the past year.

C. difficile colitis is treated with metronidazole, and earlier literature on this subject, written in the 1980's and early 1990s, suggests that the response rate is excellent, exceeding 90-95%. Our clinical observation has suggested that treatment with metronidazole is followed by a surprisingly high rate of failure, perhaps 25-30%. The clinical problem is that there are, at present, no desirable alternatives. Vancomycin, given orally, is said to be highly effective in treating this infection, but this may not be true, and the administration of this drug is associated with emergence of vancomycin-resistant bacteria, a major problem in modern hospitals. No other drug is approved for treatment of C. difficile infection.

We believe it is important to determine the actual rate of failure of treatment with metronidazole. This will provide an impetus for developing new therapeutic approaches.

We will review the records of patients who have been treated for confirmed C. difficile infection with metronidazole at the VAMC for the past 12 months in order to determine the rates of cure, failure, and relapse following therapy. This is a simple record review study to determine if our clinical suspicion is correct, namely, if the rate of failure of metronidazole therapy is much higher than that reported in the medical literature of 10-15 years ago.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • records of patients who have a fecal sample positive for C. difficile toxin and who are then treated for C. difficile colitis with oral metronidazole will be included in this study.

Exclusion Criteria:

  • Patients who did not receive at least 7 days of metronidazole
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00304369


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

Responsible Party: Daniel M. Musher MD, Principle Investigator, VA Medical Center, Houston
ClinicalTrials.gov Identifier: NCT00304369     History of Changes
Other Study ID Numbers: H-16175
First Submitted: March 16, 2006
First Posted: March 17, 2006
Last Update Posted: February 18, 2013
Last Verified: February 2013

Keywords provided by Daniel M. Musher MD, VA Medical Center, Houston:
Clostridium difficile

Additional relevant MeSH terms:
Colitis
Enterocolitis
Enterocolitis, Pseudomembranous
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents