Intracolonic Vancomycin Therapy in Severe C. Diff Colitis

NCT01346059 | Terminated Results DMC

• 1 other identifier: 2010-195
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colitis

Keywords

Clostridium; Colitis; Intracolonic vancomycin; psuedomembranous colitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Mortality

  30 day

• Need for Colectomy

  30 day

Study Arms (2)

Saline

PLACEBO COMPARATOR

The saline arm will receive normal saline through the catheter as a placebo.

Drug: Saline

Vancomycin

EXPERIMENTAL

The vancomycin arm will receive vancomycin solution through the catheter.

Drug: Vancomycin

Interventions

Vancomycin DRUG

Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline.

Also known as: Vancocin

Vancomycin

Saline DRUG

Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used.

Also known as: Normal Saline

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SICU patient
• positive c. diff toxin assay
• visualization of pseudomembranes on colonoscopy,
• able to give consent or have representative to give consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Colitis

Interventions

Vancomycin; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Technical problems with catheters becoming dislodged from the ideal site of placement (cecum) leading to unreliable data.

Results Point of Contact

• Title: Rose Callahan
• Organization: Beaumont Health

rose.callahan@beaumont.org

248 551-5147

Study Officials

• Marc B Grodsky, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: May 2, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)