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Trial record 56 of 515 for:    VANCOMYCIN

Intracolonic Vancomycin Therapy in Severe C. Diff Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):
William Beaumont Hospitals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Colitis
Interventions Drug: Vancomycin
Drug: Saline
Enrollment 2
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Saline Vancomycin
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 1 1
Completed 0 1
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Saline Vancomycin Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
1
 100.0%
1
 100.0%
2
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
1
 100.0%
1
 100.0%
2
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Resolution of Diarrhea and White Blood Cell Count Elevation
Hide Description If the patient has resolution of diarrhea, white blood cell count, and abdominal pain, the protocol will be stopped.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Vancomycin
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
2.Secondary Outcome
Title Mortality
Hide Description Death within 30 days of enrollment, in or out of hospital
Time Frame 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Vancomycin
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Need for Colectomy
Hide Description Partial or complete colectomy performed within 30 days of enrollment
Time Frame 30 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Saline Vancomycin
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline Vancomycin
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Saline Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Saline Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Saline Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Early termination leading to small numbers of subjects analyzed. Technical problems with catheters becoming dislodged from the ideal site of placement (cecum) leading to unreliable data.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Rose Callahan
Organization: Beaumont Health
Phone: 248 551-5147
Responsible Party: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01346059     History of Changes
Other Study ID Numbers: 2010-195
First Submitted: March 3, 2011
First Posted: May 2, 2011
Results First Submitted: December 13, 2016
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017