Children who are suspected for multi-drug resistant (MDR) gram negative bacterial infection Pharmacokinetic parameters pharmacokinetics colistin loading dose pediatric children MDROs
Conditions
Interventions
loading dose 4 mg/kg IV in 5 minutes follow by maintenance dose 5 mg/kg/day divided into q 8-
12 hr IV in 5 minutes start after loading dose 8-
12 hr
,maintenance dose 5 mg/kg/day divided into q 8-
12 hr IV in 5 minutes
Experimental Drug,Experimental Drug
loading dose,no loading dose
Sponsors
-
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
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
Exclusion criteria: creatinine clearance lower than 60 mL/min/1.73m2 body weight less than 10 kg pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 NGAL | — |
Countries
Thailand
Contacts
Public ContactNoppadol Wacharachaisurapol
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed