Clinical trial NCT02456974: Antibiotic Dosing in Pediatric Intensive Care
Official title: Antibiotic Dosing in Pediatric Intensive Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pharmacokinetics
Amoxicillin-clavulanate
Piperacillin-tazobactam
Vancomycin
Teicoplanin
Meropenem
Ciprofloxacin
Amikacin
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
name: Queen Fabiola Children's University Hospital, Brussels
First posted: 2015-05-29
Enrollment: 640
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children admitted to a neonatal or pediatric intensive care unit

Brief summary: Pharmacokinetics of antibiotics in critically ill neonates, infants and children


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 )

Primary outcomes:
measure: To investigate if first-dose blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens.
timeFrame: 2 years (expected)
measure: To investigate if steady-state blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens.
timeFrame: 2 years (expected)
Secondary outcomes:
measure: To compare measured first-dose blood concentrations with predefined pharmacodynamic targets (Time above MIC)
timeFrame: 2 years (expected)
measure: To compare measured steady-state blood concentrations with predefined pharmacodynamic targets (Time above MIC)
timeFrame: 2 years (expected)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital, Hospital Pharmacy
Study officials:
affiliation: University Hospital, Ghent
name: Pieter De Cock
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.