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Extended Treatment With Vancomycin for Clostridium Difficile Colitis

This study has been withdrawn prior to enrollment.
(Difficult enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00861887
First Posted: March 16, 2009
Last Update Posted: December 14, 2016
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.
Collaborator:
Beaumont Hospital
Information provided by (Responsible Party):
Mihaela Batke, William Beaumont Hospitals
  Purpose

BACKGROUND: Clostridium difficile-associated colitis is an infection of the large bowel, usually associated with previous use of antibiotics. The disease course may be complicated by fulminant disease requiring removal of the colon or by multiple recurrences requiring re-hospitalization. The incidence and severity of Clostridium difficile infection is rising, and it poses an increasing burden on the health system. For example, in one of our previous studies we found that 804 in-patients and 568 out-patients had a positive test for Clostridium difficile toxin at Beaumont Laboratories in 2003. The standard treatment is a 2 week course of Vancomycin or Metronidazole. The clinical response to Metronidazole appears to be declining, and many practicing clinicians prefer Vancomycin as a first-line treatment. The recurrence rate after the treatment is similar for Vancomycin and Metronidazole and is usually in the range of 15-25%, although recent reports noted a recurrence rate up to 50% during outbreaks with a virulent strain. Recently, it has been suggested that a 2 week duration of treatment might not be adequate in clearing the infection.

Our HYPOTHESIS is that a prolongation of Vancomycin treatment from 2 weeks to 4 weeks will lead to a decrease rate of recurrent Clostridium Difficile colitis.


Condition Intervention
Clostridium Difficile Colitis Drug: Standard Vancomycin Drug: Extended Vancomycin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of 2 Weeks Versus 4 Weeks Treatment With Vancomycin for Clostridium Difficile Colitis

Resource links provided by NLM:


Further study details as provided by Mihaela Batke, William Beaumont Hospitals:

Primary Outcome Measures:
  • compare the incidence of recurrent Clostridium difficile-associated colitis (CDAD) after a standard 2 week versus a prolonged 4 week course of treatment with Vancomycin [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • assess the response rate to Vancomycin in patients with the first episode of CDAD [ Time Frame: 2 weeks ]

Enrollment: 0
Study Start Date: February 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vancomycin
Vancomycin 125 mg every 6 hours x 4 weeks
Drug: Standard Vancomycin
Vancomycin treatment 125 mg po every 6 hours x 2 weeks
Drug: Extended Vancomycin
Vancomycin 125 mg every 6 hours x 2 weeks
Placebo Comparator: Placebo
Vancomycin 125 mg every 6 hours x 2 weeks, followed by placebo every 6 hours x 2 weeks
Drug: Standard Vancomycin
Vancomycin treatment 125 mg po every 6 hours x 2 weeks

Detailed Description:

METHODOLOGY: Patients with a first episode of Clostridium difficile colitis will be offered a prolonged course of Vancomycin. It will be disclosed that this is not the standard of care, but that a prolonged course might decrease the relapse rate. After the initial treatment with Vancomycin 125 mg four times daily, the patients will be randomly assigned to receive either 2 weeks of Vancomycin 125 mg four times daily or 2 weeks of placebo. The placebo solution will be prepared by our pharmacy to match the color and taste of the Vancomycin solution. The initial 2 weeks of therapy for both groups will be dispensed at patients' pharmacy. Patients will be called back at the end of 2 weeks and the blinded-phase drugs will be dispensed by our pharmacy staff.

We will ask permission for a follow-up phone call at the end of treatment (1 month) and at a 3-month interval. The patients will be followed longitudinally for a 3-month period. At the end of the follow-up interval, a review of any new medical records of the patient will be made and the patient will be contacted by phone for further details.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First episode of Clostridium difficile colitis, defined by a positive toxin assay plus at least one of the following: diarrhea, toxic megacolon or leukocytosis.

Exclusion Criteria:

  • previous diagnosis of Clostridium difficile colitis
  • concomitant use of oral Metronidazole, Rifampin, Rifaximin, Nitazoxanide, Sacharromyce boulardii or Lactobacillus spp.
  • age less than 18 years-old
  • pregnancy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00861887


Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Beaumont Hospital
  More Information

Publications:
Responsible Party: Mihaela Batke, Physician, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00861887     History of Changes
Other Study ID Numbers: HIC 2008-173
RC 98690
First Submitted: March 13, 2009
First Posted: March 16, 2009
Last Update Posted: December 14, 2016
Last Verified: January 2010
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mihaela Batke, William Beaumont Hospitals:
Clostridium difficile
colitis
recurrence
relapse
Vancomycin

Additional relevant MeSH terms:
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents