Intracolonic Vancomycin Therapy in Severe C. Diff Colitis
Status:
Terminated
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
Clostridium difficile is a bacteria that can infect the colon and cause severe diarrhea in
patients after recent antibiotic use. The current standard of care treatment for severe C.
diff. consists of oral vancomycin and/or intravenous metronidazole. When treatment is
unsuccessful, it can lead to need for removal of the entire colon or even death. In fact,
mortality rates in the literature range from 11-37% for C. diff. The most commonly quoted
mortality rate is 14% for severe infection. It is believed that the failure of treatment may
stem from an adynamic ileus (paralysis of the small bowel). This ileus may prevent the oral
vancomycin from reaching the colon and therefore it does not treat the problem. Vancomycin
functions by direct contact with the colon. Therefore, if the vancomycin is instilled
directly into the colon, it can come into contact with and be its intended target. : The
objective of the study is to improve treatment of severe C. diff. colitis . C. diff.
infection is defined as severe if there is evidence of ileus accompanied by any one of the
following: fever greater than 38.30C, , acidemia, serum albumin less than 2.5, or white blood
cell count greater than 14,000.