Response of Clostridium Difficile Infection to Metronidazole Therapy

This study has been completed.
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Daniel M. Musher MD, VA Medical Center, Houston
ClinicalTrials.gov Identifier:
NCT00304369
First received: March 16, 2006
Last updated: February 14, 2013
Last verified: February 2013
  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 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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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. Houston VA Medical Center
  More Information

No publications provided

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
Study First Received: March 16, 2006
Last Updated: February 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by VA Medical Center, Houston:
Clostridium difficile

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

ClinicalTrials.gov processed this record on October 21, 2014