Pediatric patients infected with multi-drug resistant gram negative bacteria who need to receive intravenous colistin colistin population pharmacokinetics pediatric MDROs
Conditions
Interventions
The colistin dosing is suggested from study protocol but the responding physicians can freely choose colistin dose that they want to prescribe. The dose variation can be managed by NONMEM program for
Experimental Drug
Plasma colistin level determination
Sponsors
Principal investigator
Eligibility
Sex/Gender
All
Age
1 Months to 12 Years
Inclusion criteria
Inclusion criteria: - Adequate vascular access to enable blood collection - Written informed consent by a caregiver
Exclusion criteria
Exclusion criteria: - Body weight < 3 kilograms - Receiving intravenous colistin > 5 doses at the day of enrollment - Receiving renal replacement therapy - Received any route of colistin within 14 days prior to the day of enrollment - Concomitantly receiving another route of colistin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of population randomly sampling blood for colistin level | — |
Secondary
| Measure | Time frame |
|---|---|
| factor affecting colistin pharmacokinetic parameters at the initiation of colistin injection data record: body weight, age, sex, serum albumin, serum creatinine, hematocrit,recommended dose of colistin at the end of mg/kg/day of colistin will be suggested according to PK parameters | — |
Countries
Thailand
Contacts
Public ContactNoppadol Wacharachaisurapol
Clinical Pharmacokinetics and Pharmacogenomics Research Unit, Department of Pharmacology, Faculty of
Outcome results
None listed