ClinicalTrials.gg
CompletedNCT00304369Updated Feb 18, 2013

Response of Clostridium Difficile Infection to Metronidazole Therapy

An observational study in Clostridium Enterocolitis, Pseudomembranous Colitis and Antibiotic-Associated Colitis, sponsored by Michael E. DeBakey VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2013-02-18.

Sponsored by Michael E. DeBakey VA Medical Center · Observational

Study type
Observational
Enrollment
290
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Clostridium Enterocolitis
  • Pseudomembranous Colitis
  • Antibiotic-Associated Colitis

Keywords

  • Clostridium difficile
03

In context

Enterocolitis, Pseudomembranous

43 studies on the registry are indexed under Enterocolitis, Pseudomembranous; 5 are open to participants now.

Browse Enterocolitis, Pseudomembranous studies →

Lead sponsor

Michael E. DeBakey VA Medical Center is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients who did not receive at least 7 days of metronidazole
05

Study design

Enrollment
290 participants (estimated)

Interventions

06

Study locations

1 site
  • Michael E. Debakey VA Medical Center
    Houston, Texas 77030, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00304369
Lead sponsor
Michael E. DeBakey VA Medical Center
Responsible party
Daniel M. Musher MD (Principle Investigator, Michael E. DeBakey VA Medical Center) — Principal investigator
First posted
Mar 17, 2006
Start date
Jun 2005
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Feb 18, 2013

Study contacts

Daniel M Musher, M.D.
principal investigator · Michael E. DeBakey VA Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion