multidrug resistant gram negative bacteria (MDR GNB) intravenous colistin Population pharmacokinetics colistimethate sodium (CMS) colistin intravenous pediatric patients
Conditions
Interventions
CMS intravenous infusion over 30 minutes every 8 or 12 hours according to a dosage regimen prescribed by the physician
Treatment
Colistin
Sponsors
Graduate School, Chiang Mai University
National Research Council of Thailand (NRCT)
Eligibility
Sex/Gender
All
Age
1 Years to 17 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactSunisa Khamlek
PhD student, Faculty of Pharmacy, Chiang Mai University (principal investigator)
Outcome results
None listed