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| Sponsors and Collaborators: |
William Beaumont Hospitals Beaumont Hospital |
|---|---|
| Information provided by: | William Beaumont Hospitals |
| ClinicalTrials.gov Identifier: | NCT00861887 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
| Official Title: | Comparative Study of 2 Weeks Versus 4 Weeks Treatment With Vancomycin for Clostridium Difficile Colitis |
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Vancomycin: Active Comparator
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: Placebo Comparator
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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mihaela Batke, MD | 248.898.5000 ext 80467 | mihaela.batke@beaumont.edu |
| Contact: Aditi Swami, MD | 248.898.5000 | ASwami@beaumont.edu |
| United States, Michigan | |
| William Beaumont Hospital | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Principal Investigator: Mihaela Batke, MD | |
| Sub-Investigator: Aditi Swami, MD | |
| Sub-Investigator: Christopher Carpenter, MD | |
| Sub-Investigator: Mitchell Cappell, MD, PhD | |
| Sub-Investigator: Navakanth Gorrepati, MD | |
| Sub-Investigator: Amulya Konda, MD | |
| Sub-Investigator: Mahmoud Lajin, MD | |
| Sub-Investigator: Tajal Mehta, MD | |
| Sub-Investigator: Philip Kadaj, MD | |
More Information
| Responsible Party: | William Beaumont Hospitals ( Mihaela Batke, principal investigator ) |
| Study ID Numbers: | HIC 2008-173, RC 98690 |
| Study First Received: | March 13, 2009 |
| Last Updated: | March 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00861887 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Clostridium difficile colitis recurrence relapse Vancomycin |
|
Anti-Bacterial Agents Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Vancomycin |
Clostridium Difficile Intestinal Diseases Gastroenteritis Colitis Recurrence |
|
Anti-Infective Agents Anti-Bacterial Agents Digestive System Diseases Gastrointestinal Diseases Therapeutic Uses Colonic Diseases |
Vancomycin Intestinal Diseases Gastroenteritis Colitis Pharmacologic Actions |
