Extended Treatment With Vancomycin for Clostridium Difficile Colitis
Status:
Withdrawn
Trial end date:
2010-01-01
Target enrollment:
Participant gender:
Summary
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.