Intracolonic Vancomycin Therapy in Severe C. Diff Colitis
Intracolonic Vancomycin Therapy in Severe C. Diff Colitis
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.
Patients in the surgical intensive care unit with severe C. diff. are eligible and if
 consented will be randomized in a 1:1 ratio to a control group or the treatment group. Each
 group will undergo a colonoscopy on day one of the study. A 14 French Cook colonic
 decompression catheter will be placed at that time. This catheter is a 175cm long soft
 flexible catheter designed to be placed in the colon. Its usual use is to remove air from a
 colon that is dilated. The catheter is placed into the colon by first placing a guidewire
 through the colonoscope. The colonoscope is then removed leaving the guidewire in place. The
 catheter is then thread into the colon over the guidewire. An xray is obtained to confirm the
 location of the catheter and then the guidewire is removed. The guidewire is a very thin,
 soft, flexible wire. The patient will not have any undue discomfort secondary to the
 catheter. The control group will have 250cc of sterile saline solution instilled through the
 catheter into the colon every 6 hours. The study group will have 250cc of vancomycin solution
 instilled every 6 hours. The solution will be 2 grams vancomycin dissolved in a 1 liter
 normal saline irrigation bottle. The catheter will be clamped in both groups after
 instillation until the next treatment. Of note, both groups will receive the current standard
 treatment of 500mg IV metronidazole every 8 hours and 250mg oral vancomycin every 6 hours
 throughout the study. Every day the patients will have a blood draw to check the white blood
 cell count as is the current practice. The patients will also have a vancomycin trough level
 checked via blood test. This will occur just prior to the first dosing on treatment day
 number 3. This will be a blinded lab value as to not unblind the investigators. At resolution
 Patients will undergo a repeat colonoscopy when there is a decrease of diarrhea (less than 3
 stools daily) and a normalized white blood cell count or on day 7 if symptoms persist. The
 expected length of treatment is approximately 7 days. If there is no improvement at fourteen
 days, the trial will be stopped for futility. The trial will also be halted if the attending
 physician determines that the patient needs surgery or if the clinical status of the patient
 has deteriorated to a point where keeping the patient enrolled will potentially cause harm.
 Follow-up after completing the trial will consist of phone interviews to screen for
 recurrence of infection. A weekly phone call will be made for the first three weeks and then
 two monthly calls will take place after that for a total of three months follow-up. The
 primary investigator will make these phone calls.
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.