Trial Outcomes & Findings for Intracolonic Vancomycin Therapy in Severe C. Diff Colitis (NCT NCT01346059)

NCT ID: NCT01346059

Last Updated: 2017-03-29

Results Overview

If the patient has resolution of diarrhea, white blood cell count, and abdominal pain, the protocol will be stopped.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2017-03-29

Participant Flow

All patients enrolled undergo a complete colonoscopy with placement of a 14 French colon decompression catheter (Cook Medical). Proper placement of the catheter in the cecum is verified by abdominal X-ray. Patients are randomized to either Saline or Vancomycin arms.

Participant milestones

Measure	Saline The saline arm will receive normal saline through the catheter as a placebo. Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used.	Vancomycin The vancomycin arm will receive vancomycin solution through the catheter. Vancomycin: 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.
Overall Study STARTED	1	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Saline The saline arm will receive normal saline through the catheter as a placebo. Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used.	Vancomycin The vancomycin arm will receive vancomycin solution through the catheter. Vancomycin: 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.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Intracolonic Vancomycin Therapy in Severe C. Diff Colitis

Baseline characteristics by cohort

Measure	Saline n=1 Participants The saline arm will receive normal saline through the catheter as a placebo. Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used.	Vancomycin n=1 Participants The vancomycin arm will receive vancomycin solution through the catheter. Vancomycin: 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.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

If the patient has resolution of diarrhea, white blood cell count, and abdominal pain, the protocol will be stopped.

Outcome measures

Measure	Saline The saline arm will receive normal saline through the catheter as a placebo. Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used.	Vancomycin n=1 Participants The vancomycin arm will receive vancomycin solution through the catheter. Vancomycin: 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.
Resolution of Diarrhea and White Blood Cell Count Elevation	—	1 Participants

SECONDARY outcome

Timeframe: 30 day

Death within 30 days of enrollment, in or out of hospital

Outcome measures

Measure	Saline The saline arm will receive normal saline through the catheter as a placebo. Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used.	Vancomycin n=1 Participants The vancomycin arm will receive vancomycin solution through the catheter. Vancomycin: 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.
Mortality	—	0 Participants

SECONDARY outcome

Timeframe: 30 day

Partial or complete colectomy performed within 30 days of enrollment

Outcome measures

Measure	Saline The saline arm will receive normal saline through the catheter as a placebo. Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used.	Vancomycin n=1 Participants The vancomycin arm will receive vancomycin solution through the catheter. Vancomycin: 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.
Need for Colectomy	—	0 Participants

Adverse Events

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vancomycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rose Callahan

Beaumont Health

Phone: 248 551-5147

Email: rose.callahan@beaumont.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place