Extended Treatment With Vancomycin for Clostridium Difficile Colitis
Withdrawn before enrolling · Not applicable · Has a placebo group
Conditions studied: Clostridium Difficile Colitis
In brief
BACKGROUND: Clostridium difficile-associated colitis is an infection of the large bowel, usually associated with previous use of antibiotics. The disease course may be complicated by fulminant disease requiring removal of the colon or by multiple recurrences requiring re-hospitalization. The incidence and severity of Clostridium difficile infection is rising, and it poses an increasing burden on the health system. For example, in one of our previous studies we found that 804 in-patients and 568 out-patients had a positive test for Clostridium difficile toxin at Beaumont Laboratories in 2003. The standard treatment is a 2 week course of Vancomycin or Metronidazole. The clinical response to Metronidazole appears to be declining, and many practicing clinicians prefer Vancomycin as a first-line treatment. The recurrence rate after the treatment is similar for Vancomycin and Metronidazole and is usually in the range of 15-25%, although recent reports noted a recurrence rate up to 50% during outbreaks with a virulent strain. Recently, it has been suggested that a 2 week duration of treatment might not be adequate in clearing the infection. Our HYPOTHESIS is that a prolongation of Vancomycin treatment from 2 weeks to 4 weeks will lead to a decrease rate of recurrent Clostridium Difficile colitis.
Key facts
- Study ID
- NCT00861887
- Run by
- Corewell Health East
- People needed
- 0
- Starts
- 2009-02-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2016-12-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- First episode of Clostridium difficile colitis, defined by a positive toxin assay plus at least one of the following: diarrhea, toxic megacolon or leukocytosis.
You may not qualify if…
- previous diagnosis of Clostridium difficile colitis
- concomitant use of oral Metronidazole, Rifampin, Rifaximin, Nitazoxanide, Sacharromyce boulardii or Lactobacillus spp.
- age less than 18 years-old
- pregnancy.
Where it is running
- William Beaumont Hospital — Royal Oak, Michigan, United States
Full record on ClinicalTrials.gov
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