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

Multidrug-resistant Gram-negative Bacteria Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007290
• Other study ID #: Colistin_TDM
• Status: Completed
• Phase: N/A
• First received: December 28, 2016
• Last updated: April 16, 2018
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gram-Negative Bacterial Infections
• Multidrug-resistant Gram-negative Bacteria Infection

Intervention

Other:
• Therapeutic drug monitoring
Therapeutic drug monitoring for colistin

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AKI	Emergence rate of acute kidney injury	Through study completion, an average of 1 month
Secondary	Death	Death rate	Through study completion, an average of 1 month
Secondary	Negative conversion rate	Culture-negative conversion rate Treatment success Treatment success	Through study completion, an average of 1 month