Intracolonic Vancomycin Therapy in Severe C. Diff Colitis
|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
|Condition or disease||Intervention/treatment||Phase|
|Colitis||Drug: Vancomycin Drug: Saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Intracolonic Vancomycin Therapy in Severe C. Diff Colitis: A Double Blinded Randomized Prospective Trial|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Placebo Comparator: Saline
The saline arm will receive normal saline through the catheter as a placebo.
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
The vancomycin arm will receive vancomycin solution through the catheter.
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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346059
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Marc B Grodsky, MD||William Beaumont Hospitals|