Population pharmacokinetics and pharmacodynamics of colistimethate sodium (CMS) and colistin after intravenous administration in pediatric patients

Not Applicable

Recruiting

• Conditions: multidrug resistant gram negative bacteria (MDR GNB)intravenous colistin; Population pharmacokinetics; colistimethate sodium (CMS); colistin; intravenous; pediatric patients

• Registration Number: TCTR20181001003
• Lead Sponsor: Graduate School, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Study Completion: 2021-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age 1 †<18 years old
2. Having indication for the use of IV colistin treatment
3. Having a stable renal function during 1 week before the initiation of IV
colistin treatment

Exclusion Criteria

1. Hypersensitive to colistin or any component of the formulation
2. During pregnancy or breastfeeding
3. Had received or will receive renal replacement therapy
4. Diagnosed as having cystic fibrosis
5. Having obesity (%weight-for-height >140)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Population pharmacokinetic model of CMS and colistin at the first dose and any specific dose on day 3 of intravenous administration of CMS Population pharmacokinetic modeling analysis

Secondary Outcome Measures

Name	Time	Method
Optimal dosage regimen of CMS for pediatric patients After completing the step of internal model validation Monte Carlo Simulation,Pharmacokinetic/pharmacodynamic (PK/PD) relationships At the end of colistin treatment Regression analysis and coefficient of correlation