Back to resultsClinical Usefulness of Therapeutic Drug Monitoring of Colistin in Patients Treated With Colistin.
Primary Purpose
Multidrug-resistant Gram-negative Bacteria Infection
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Therapeutic drug monitoring
Sponsored by
About this trial
This is an interventional health services research trial for Multidrug-resistant Gram-negative Bacteria Infection
Eligibility Criteria
Inclusion Criteria:
- Age over 18 years old.
- Those who receive colistin therapy for the treatment of multi-drug resistant gram negative bacteria infection.
Exclusion Criteria:
- Those who received colistin therapy less than 48 hours
- Those who received colistin therapy through the bronchus
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group
Arm Description
Group with therapeutic drug monitoring
Outcomes
Primary Outcome Measures
AKI
Emergence rate of acute kidney injury
Secondary Outcome Measures
Death
Death rate
Negative conversion rate
Culture-negative conversion rate Treatment success Treatment success
Full Information
NCT ID
NCT03007290
First Posted
December 28, 2016
Last Updated
April 16, 2018
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03007290
Brief Title
Clinical Usefulness of Therapeutic Drug Monitoring of Colistin in Patients Treated With Colistin.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical usefulness of therapeutic drug monitoring of colistin in patients treated with colistin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multidrug-resistant Gram-negative Bacteria Infection
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Group with therapeutic drug monitoring
Intervention Type
Other
Intervention Name(s)
Therapeutic drug monitoring
Intervention Description
Therapeutic drug monitoring for colistin
Primary Outcome Measure Information:
Title
AKI
Description
Emergence rate of acute kidney injury
Time Frame
Through study completion, an average of 1 month
Secondary Outcome Measure Information:
Title
Death
Description
Death rate
Time Frame
Through study completion, an average of 1 month
Title
Negative conversion rate
Description
Culture-negative conversion rate Treatment success Treatment success
Time Frame
Through study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18 years old.
Those who receive colistin therapy for the treatment of multi-drug resistant gram negative bacteria infection.
Exclusion Criteria:
Those who received colistin therapy less than 48 hours
Those who received colistin therapy through the bronchus
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Usefulness of Therapeutic Drug Monitoring of Colistin in Patients Treated With Colistin.
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