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Response of Clostridium Difficile Infection to Metronidazole Therapy

Primary Purpose

Clostridium Enterocolitis, Pseudomembranous Colitis, Antibiotic-Associated Colitis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Metronidazole
Sponsored by
Michael E. DeBakey VA Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Clostridium Enterocolitis focused on measuring Clostridium difficile

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Michael E. Debakey VA Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 16, 2006
Last Updated
February 14, 2013
Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00304369
Brief Title
Response of Clostridium Difficile Infection to Metronidazole Therapy
Official Title
The Response of Clostridium Difficile Infection to Metronidazole Therapy
Study Type
Observational

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michael E. DeBakey VA Medical Center
Collaborators
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Enterocolitis, Pseudomembranous Colitis, Antibiotic-Associated Colitis
Keywords
Clostridium difficile

7. Study Design

Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Metronidazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel M Musher, M.D.
Organizational Affiliation
Michael E. DeBakey VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. Debakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Response of Clostridium Difficile Infection to Metronidazole Therapy

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