Extended Treatment With Vancomycin for Clostridium Difficile Colitis

This study has been withdrawn prior to enrollment.
(Difficult enrollment)
Sponsor:
Collaborator:
Beaumont Hospital
Information provided by:
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00861887
First received: March 13, 2009
Last updated: January 19, 2010
Last verified: January 2010
  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: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • assess the response rate to Vancomycin in patients with the first episode of CDAD [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, principal investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00861887     History of Changes
Other Study ID Numbers: HIC 2008-173, RC 98690
Study First Received: March 13, 2009
Last Updated: January 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014