Response of Clostridium Difficile Infection to Metronidazole Therapy

February 14, 2013 updated by: Daniel M. Musher MD, Michael E. DeBakey VA Medical Center

The Response of Clostridium Difficile Infection to Metronidazole Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael E. DeBakey VA Medical Center

Collaborators

Baylor College of Medicine

Investigators

  • Principal Investigator: Daniel M Musher, M.D., Michael E. DeBakey VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

March 16, 2006

First Submitted That Met QC Criteria

March 16, 2006

First Posted (Estimate)

March 17, 2006

Study Record Updates

Last Update Posted (Estimate)

February 18, 2013

Last Update Submitted That Met QC Criteria

February 14, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-16175

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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