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Response of Clostridium Difficile Infection to Metronidazole Therapy
This study is currently recruiting participants.
Verified by VA Medical Center, Houston, June 2005
First Received: March 16, 2006   No Changes Posted
Sponsors and Collaborators: VA Medical Center, Houston
Baylor College of Medicine
Information provided by: VA Medical Center, Houston
ClinicalTrials.gov Identifier: NCT00304369
  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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304369

Contacts
Contact: Daniel M Musher, M.D. 713-794-7384 dmusher@bcm.tmc.edu
Contact: Nancy L Logan, M.D. 713-794-7384 njarrar@bcm.tmc.edu

Locations
United States, Texas
Michael E. Debakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Daniel M Musher, MD     713-794-7384     dmusher@bcm.tmc.edu    
Principal Investigator: Daniel M Musher, M.D.            
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

Study ID Numbers: H-16175
Study First Received: March 16, 2006
Last Updated: March 16, 2006
ClinicalTrials.gov Identifier: NCT00304369     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by VA Medical Center, Houston:
Clostridium difficile

Study placed in the following topic categories:
Bacterial Infections
Anti-Infective Agents
Metronidazole
Gastrointestinal Diseases
Colonic Diseases
Enterocolitis, Pseudomembranous
Clostridium Difficile
Intestinal Diseases
Enterocolitis
Gram-Positive Bacterial Infections
Digestive System Diseases
Radiation-Sensitizing Agents
Clostridium Infections
Gastroenteritis
Colitis

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

ClinicalTrials.gov processed this record on August 24, 2009