Extended Treatment With Vancomycin for Clostridium Difficile Colitis
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|ClinicalTrials.gov Identifier: NCT00861887|
Recruitment Status : Withdrawn (Difficult enrollment)
First Posted : March 16, 2009
Last Update Posted : December 14, 2016
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 or disease||Intervention/treatment||Phase|
|Clostridium Difficile Colitis||Drug: Standard Vancomycin Drug: Extended Vancomycin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparative Study of 2 Weeks Versus 4 Weeks Treatment With Vancomycin for Clostridium Difficile Colitis|
|Study Start Date :||February 2009|
|Estimated Primary Completion Date :||November 2009|
|Estimated Study Completion Date :||January 2010|
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 weeksDrug: 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
- 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 ]
- assess the response rate to Vancomycin in patients with the first episode of CDAD [ Time Frame: 2 weeks ]
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
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|