NCT03007290

Brief Summary

Clinical usefulness of therapeutic drug monitoring of colistin in patients treated with colistin

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

December 28, 2016

Last Update Submit

April 16, 2018

Conditions

Multidrug-resistant Gram-negative Bacteria Infection

Outcome Measures

Primary Outcomes (1)

  • AKI

    Emergence rate of acute kidney injury

    Through study completion, an average of 1 month

Secondary Outcomes (2)

  • Death

    Through study completion, an average of 1 month

  • Negative conversion rate

    Through study completion, an average of 1 month

Study Arms (1)

Treatment group

EXPERIMENTAL

Group with therapeutic drug monitoring

Other: Therapeutic drug monitoring

Interventions

Therapeutic drug monitoringOTHER

Therapeutic drug monitoring for colistin

Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years old.
  • Those who receive colistin therapy for the treatment of multi-drug resistant gram negative bacteria infection.

You may not qualify if:

  • Those who received colistin therapy less than 48 hours
  • Those who received colistin therapy through the bronchus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 28, 2016

First Posted

January 2, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

April 18, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)