Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
640 participants
OBSERVATIONAL
2012-05-31
2025-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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amoxicillin-clavulanate
Patients receiving amoxicillin-clavulanate as part of routine clinical care.
blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care
piperacilline-tazobactam
Patients receiving piperacilline-tazobactam as part of routine clinical care.
blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care.
vancomycin
Patients receiving vancomycin as part of routine clinical care.
blood sampling in patients receiving vancomycin as part of routine clinical care.
teicoplanin
Patients receiving teicoplanin as part of routine clinical care.
blood sampling in patients receiving teicoplanin as part of routine clinical care.
meropenem
Patients receiving meropenem as part of routine clinical care.
blood sampling in patients receiving meropenem as part of routine clinical care.
ciprofloxacin
Patients receiving ciprofloxacin as part of routine clinical care.
blood sampling and urine smapling in patients receiving ciprofloxacin as part of routine clinical care.
amikacin
Patients receiving amikcain as part of routine clinical care.
blood sampling in patients receiving amikacin as part of routine clinical care.
Interventions
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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.
blood sampling in patients receiving meropenem as part of routine clinical care.
blood sampling and urine smapling in patients receiving ciprofloxacin as part of routine clinical care.
blood sampling in patients receiving amikacin as part of routine clinical care.
Eligibility Criteria
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Inclusion Criteria
* 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
* absence of parental/patient consent
* known hypersensitivity to beta-lactam antibiotics, glycopeptides, fluoroquinolones, aminoglycosides
* extracorporeal circuit (haemodialysis, ECMO, peritoneal dialysis )
1 Day
16 Years
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Queen Fabiola Children's University Hospital, Brussels
UNKNOWN
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Pieter De Cock
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent University Hospital, Hospital Pharmacy
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Pieter De Cock, PharmD
Role: primary
References
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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. Epub 2025 Apr 15.
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.
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.
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.
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.
Other Identifiers
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2012/172
Identifier Type: -
Identifier Source: org_study_id