Recruiting NCT02456974

Antibiotic Dosing in Pediatric Intensive Care

— Observational Pharmacokinetics Amoxicillin-clavulanate Piperacillin-tazobactam Vancomycin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care, blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care., blood sampling in patients receiving vancomycin as part of routine clinical care., blood sampling in patients receiving teicoplanin as part of routine clinical care..
Who it may be relevant to: Registry conditions: Pharmacokinetics, Amoxicillin-clavulanate, Piperacillin-tazobactam, Vancomycin. Basic parameters: 1 Day — 16 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Belgium
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Pharmacokinetics of antibiotics in critically ill neonates, infants and children

Interventions

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 in patients receiving vancomycin as part of routine clinical care.
Procedure blood sampling in patients receiving teicoplanin as part of routine clinical care.
Procedure blood sampling in patients receiving meropenem as part of routine clinical care.
Procedure blood sampling and urine smapling in patients receiving ciprofloxacin as part of routine clinical care.
Procedure blood sampling in patients receiving amikacin as part of routine clinical care.

Primary outcome measures

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

Secondary outcome measures (2)

To compare measured first-dose blood concentrations with predefined pharmacodynamic targets (Time above MIC) [Time frame: 2 years (expected)]
To compare measured steady-state blood concentrations with predefined pharmacodynamic targets (Time above MIC) [Time frame: 2 years (expected)]

Eligibility criteria

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 )

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Other

Study locations

Belgium · 1 center

Ghent University Hospital, Hospital Pharmacy — Ghent

Publications

Dhont E, Standing JF, Beel E, Nguyen TVA, Herck I, Peperstraete H, Vandenberghe W, Bove T, Vandekerckhove K, Verougstraete N, Stove V, Vande Walle J, De Paepe P, De Cock PA. Individualised amoxicillin-clavulanate dosing recommendations for critically ill children with augmented clearance after cardiac surgery. Int J Antimicrob Agents. 2025 Aug;66(2):107513. doi: 10.1016/j.ijantimicag.2025.107513. PMID 40239747
Van Der Heggen T, Dhont E, Willems J, Herck I, Delanghe JR, Stove V, Verstraete AG, Vanhaesebrouck S, De Paepe P, De Cock PAJG. Suboptimal Beta-Lactam Therapy in Critically Ill Children: Risk Factors and Outcome. Pediatr Crit Care Med. 2022 Jul 1;23(7):e309-e318. doi: 10.1097/PCC.0000000000002951. Epub 2022 Apr 15. PMID 35426861
Aulin LBS, De Paepe P, Dhont E, de Jaeger A, Vande Walle J, Vandenberghe W, McWhinney BC, Ungerer JPJ, van Hasselt JGC, De Cock PAJG. Population Pharmacokinetics of Unbound and Total Teicoplanin in Critically Ill Pediatric Patients. Clin Pharmacokinet. 2021 Mar;60(3):353-363. doi: 10.1007/s40262-020-00945-4. Epub 2020 Oct 8. PMID 33030704
De Cock PA, Desmet S, De Jaeger A, Biarent D, Dhont E, Herck I, Vens D, Colman S, Stove V, Commeyne S, Vande Walle J, De Paepe P. Impact of vancomycin protein binding on target attainment in critically ill children: back to the drawing board? J Antimicrob Chemother. 2017 Mar 1;72(3):801-804. doi: 10.1093/jac/dkw495. PMID 27999035
De Cock PA, Standing JF, Barker CI, de Jaeger A, Dhont E, Carlier M, Verstraete AG, Delanghe JR, Robays H, De Paepe P. Augmented renal clearance implies a need for increased amoxicillin-clavulanic acid dosing in critically ill children. Antimicrob Agents Chemother. 2015 Nov;59(11):7027-35. doi: 10.1128/AAC.01368-15. Epub 2015 Sep 8. PMID 26349821

Identifiers

NCT: NCT02456974 · 2012/172

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗