Intracolonic Vancomycin Therapy in Severe C. Diff Colitis

• Status: Terminated
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marc Grodsky; William Beaumont Hospitals
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• SICU patient

• positive c. diff toxin assay

• visualization of pseudomembranes on colonoscopy,

• able to give consent or have representative to give consent.

Exclusion Criteria:

• Under age 18

• pregnant

• absence of a colon or surgical discontinuity of bowel

• allergy to vancomycin

• need for anti-diarrheal medication

• need for prolonged antibiotics for other cause

• need for probiotics

• need for other medications with action against C. diff.

• need for surgery, colon perforation

• recent IV IG use

• toxic megacolon.