Clinical Usefulness of Therapeutic Drug Monitoring of Col... | NCT03007290

Studies
Clinical Usefulness of Therapeutic Drug Monitoring of Colistin in Patients Treated With Colistin.

NCT03007290

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Apr 18, 2018Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Multidrug-resistant Gram-negative Bacteria Infection

Interventions

Therapeutic drug monitoring

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Dec 28, 2016

First Submission Date that Met QC Criteria

Dec 29, 2016

First Posted Date

Jan 2, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2018

Last Update Posted Date

Apr 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eu Suk Kim, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental	Group with therapeutic drug monitoring	Other: Therapeutic drug monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Therapeutic drug monitoring	Other	Therapeutic drug monitoring for colistin	Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AKI	Emergence rate of acute kidney injury	Through study completion, an average of 1 month

Secondary Outcomes

Measure	Description	Time Frame
Death	Death rate	Through study completion, an average of 1 month
Negative conversion rate	Culture-negative conversion rate Treatment success Treatment success

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided