Antibiotic Dosing in Pediatric Intensive Care

Recruiting

• Conditions: Pharmacokinetics; Amoxicillin-clavulanate; Vancomycin; Teicoplanin; Meropenem; Ciprofloxacin; Amikacin; Piperacillin-tazobactam

• 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

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