Response of Clostridium Difficile Infection to Metronidazole Therapy



Status:Recruiting
Conditions:Colitis, Infectious Disease, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:2/4/2013
Contact:Daniel M Musher, M.D.
Email:dmusher@bcm.tmc.edu
Phone:713-794-7384

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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.


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.

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
We found this trial at
1
site
2002 Holcombe Blvd
Houston, Texas 77030
(713) 791-1414
Michael E. Debakey VA Medical Center The Michael E. DeBakey VA Medical Center serves as...
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mi
from
Houston, TX
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