Colitis Clinical Trial
Official title:
Intracolonic Vancomycin Therapy in Severe C. Diff Colitis: A Double Blinded Randomized Prospective Trial
Verified date | April 2011 |
Source | William Beaumont Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | William Beaumont Hospital | Royal Oak | Michigan |
Lead Sponsor | Collaborator |
---|---|
Marc Grodsky |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resolution of diarrhea and white blood cell count elevation | If the patient has resolution of diarrhea, white blood cell count, and abdominal pain, the protocol will be stopped. | 14 days | Yes |
Secondary | Mortality | 30 day | No | |
Secondary | Need for colectomy | 30 day | No |
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