Pharmacokinetic Study of Intravenous Colistin in Pediatric Populatio

Completed

• Conditions: Children who are suspected for multi-drug resistant (MDR) gram negative bacterial infectionPharmacokinetic parameters; pharmacokinetics; colistin; pediatric; children; loading dose; MDROs

• Registration Number: TCTR20171119001
• Lead Sponsor: -

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-19
• Study Completion: 2018-04-06
• Results First Posted: 2020-03-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Age 2-18 years old
Documented infection by multiple-resistant micro-organisms only susceptible to colistin or empirically treated for suspected MDR- GNR infection
need to receive colistin at least 72 hours
written informed consent

Exclusion Criteria

creatinine clearance lower than 60 mL/min/1.73m2
body weight less than 10 kg
pregnant women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pharmacokinetic parameters (Cmax, Tmax, AUC, T1/2) 0, 1, 2, 4, 8, 12 or 16, 24, 48, 72 hr blood sampling and colistin plasma drug level measurement

Secondary Outcome Measures

Name	Time	Method
Creatinine clearance every 1-3 days during colistin cource Blood for serum creatinine,urine NGAL before and 24, 72 hours after the first dose of colistin urine for NGA