Intracolonic Vancomycin Therapy in Severe C. Diff Colitis
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|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
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): NCT01346059
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Marc B Grodsky, MD||William Beaumont Hospitals|