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Trial record 61 of 534 for:    VANCOMYCIN

Intracolonic Vancomycin Therapy in Severe C. Diff Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01346059
Recruitment Status : Terminated (Technical issues with catheter placement; researcher left institution)
First Posted : May 2, 2011
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
William Beaumont Hospitals

Tracking Information
First Submitted Date  ICMJE March 3, 2011
First Posted Date  ICMJE May 2, 2011
Results First Submitted Date  ICMJE December 13, 2016
Results First Posted Date  ICMJE March 29, 2017
Last Update Posted Date March 29, 2017
Study Start Date  ICMJE April 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2011)
Resolution of Diarrhea and White Blood Cell Count Elevation [ Time Frame: 14 days ]
If the patient has resolution of diarrhea, white blood cell count, and abdominal pain, the protocol will be stopped.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01346059 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
  • Mortality [ Time Frame: 30 day ]
    Death within 30 days of enrollment, in or out of hospital
  • Need for Colectomy [ Time Frame: 30 day ]
    Partial or complete colectomy performed within 30 days of enrollment
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2011)
  • Mortality [ Time Frame: 30 day ]
  • Need for Colectomy [ Time Frame: 30 day ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intracolonic Vancomycin Therapy in Severe C. Diff Colitis
Official Title  ICMJE Intracolonic Vancomycin Therapy in Severe C. Diff Colitis: A Double Blinded Randomized Prospective Trial
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Colitis
Intervention  ICMJE
  • Drug: Vancomycin
    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.
    Other Name: Vancocin
  • Drug: Saline
    Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used.
    Other Name: Normal Saline
Study Arms  ICMJE
  • Placebo Comparator: Saline
    The saline arm will receive normal saline through the catheter as a placebo.
    Intervention: Drug: Saline
  • Experimental: Vancomycin
    The vancomycin arm will receive vancomycin solution through the catheter.
    Intervention: Drug: Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 15, 2012)
2
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2011)
20
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01346059
Other Study ID Numbers  ICMJE 2010-195
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party William Beaumont Hospitals
Study Sponsor  ICMJE William Beaumont Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc B Grodsky, MD William Beaumont Hospitals
PRS Account William Beaumont Hospitals
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP