Dose recommendations for intravenous colistin in pediatric patients from a prospective, multicenter, population pharmacokinetic study

Completed

• Conditions: Pediatric patients infected with multi-drug resistant gram negative bacteria who need to receive intravenous colistin; colistin population pharmacokinetics; pediatric; MDROs

• Registration Number: TCTR20180526001
• Lead Sponsor: Principal investigator

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-26
• Study Completion: 2020-11-09
• Results First Posted: 2021-06-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Adequate vascular access to enable blood collection
- Written informed consent by a caregiver

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of population randomly sampling blood for colistin level

Secondary Outcome Measures

Name	Time	Method
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