Response of Clostridium Difficile Infection to Metronidazole Therapy
Information source: VA Medical Center, Houston
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clostridium Enterocolitis; Pseudomembranous Colitis; Antibiotic-Associated Colitis
Intervention: Metronidazole (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: VA Medical Center, Houston Official(s) and/or principal investigator(s):
Daniel M Musher, M.D., Principal Investigator, Affiliation: Houston VA Medical Center
Overall contact:
Daniel M Musher, M.D., Phone: 713-794-7384, Email: dmusher@bcm.tmc.edu
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.
Clinical Details
Official title: The Response of Clostridium Difficile Infection to Metronidazole Therapy
Study design: N/A
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
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
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
Locations and Contacts
Daniel M Musher, M.D., Phone: 713-794-7384, Email: dmusher@bcm.tmc.edu
Michael E. Debakey VA Medical Center, Houston, Texas 77030, United States; Recruiting
Daniel M Musher, MD, Phone: 713-794-7384, Email: dmusher@bcm.tmc.edu
Daniel M Musher, M.D., Principal Investigator
Additional Information
Last updated: March 16, 2006
|
