Antibiotic Dosing in Pediatric Intensive Care

Recruiting

• Conditions: Pharmacokinetics; Amoxicillin-clavulanate; Vancomycin; Teicoplanin; Meropenem; Ciprofloxacin; Amikacin; Piperacillin-tazobactam
• Interventions: Procedure: blood sampling in patients receiving teicoplanin as part of routine clinical care.; Procedure: blood sampling in patients receiving amikacin as part of routine clinical care.; Procedure: blood sampling in patients receiving vancomycin as part of routine clinical care.; Procedure: blood sampling in patients receiving meropenem as part of routine clinical care.; Procedure: blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care; Procedure: blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care.; Procedure: blood sampling and urine smapling in patients receiving ciprofloxacin as part of routine clinical care.

• Registration Number: NCT02456974
• Lead Sponsor: University Hospital, Ghent

Brief Summary

Pharmacokinetics of antibiotics in critically ill neonates, infants and children

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-15
• Primary Completion: 2024-12
• Study Completion: 2025-04-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 640

Inclusion Criteria

• patients admitted to the pediatric intensive care unit
• patient age/weight : 1,8 kg-15 years
• patient receiving antibiotic treatment (piperacillin-tazobactam, amoxicillin-clavulanate, vancomycin, teicoplanin, meropenem, ciprofloxacin, amikacin) via intermittent infusion regimen or continuous infusion according to institutional treatment guidelines
• intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred)

Exclusion Criteria

• no catheter in place for blood sampling
• absence of parental/patient consent
• known hypersensitivity to beta-lactam antibiotics, glycopeptides, fluoroquinolones, aminoglycosides
• extracorporeal circuit (haemodialysis, ECMO, peritoneal dialysis )

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
teicoplanin	blood sampling in patients receiving teicoplanin as part of routine clinical care.	Patients receiving teicoplanin as part of routine clinical care.
amikacin	blood sampling in patients receiving amikacin as part of routine clinical care.	Patients receiving amikcain as part of routine clinical care.
vancomycin	blood sampling in patients receiving vancomycin as part of routine clinical care.	Patients receiving vancomycin as part of routine clinical care.
meropenem	blood sampling in patients receiving meropenem as part of routine clinical care.	Patients receiving meropenem as part of routine clinical care.
amoxicillin-clavulanate	blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care	Patients receiving amoxicillin-clavulanate as part of routine clinical care.
piperacilline-tazobactam	blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care.	Patients receiving piperacilline-tazobactam as part of routine clinical care.
ciprofloxacin	blood sampling and urine smapling in patients receiving ciprofloxacin as part of routine clinical care.	Patients receiving ciprofloxacin as part of routine clinical care.

Primary Outcome Measures

Name	Time	Method
To investigate if steady-state blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens.	2 years (expected)
To investigate if first-dose blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens.	2 years (expected)

Secondary Outcome Measures

Name	Time	Method
To compare measured first-dose blood concentrations with predefined pharmacodynamic targets (Time above MIC)	2 years (expected)
To compare measured steady-state blood concentrations with predefined pharmacodynamic targets (Time above MIC)	2 years (expected)

Trial Locations

Locations (1)

Ghent University Hospital, Hospital Pharmacy; 🇧🇪 Ghent, Belgium