Antibiotic Dosing in Pediatric Intensive Care
ADIC
1 other identifier
observational
640
1 country
1
Brief Summary
Pharmacokinetics of antibiotics in critically ill neonates, infants and children
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 18, 2015
CompletedFirst Posted
Study publicly available on registry
May 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
January 16, 2026
January 1, 2026
15.3 years
May 18, 2015
January 15, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
To investigate if first-dose blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens.
2 years (expected)
To investigate if steady-state blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens.
2 years (expected)
Secondary Outcomes (2)
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)
Study Arms (7)
amoxicillin-clavulanate
Patients receiving amoxicillin-clavulanate as part of routine clinical care.
piperacilline-tazobactam
Patients receiving piperacilline-tazobactam as part of routine clinical care.
vancomycin
Patients receiving vancomycin as part of routine clinical care.
teicoplanin
Patients receiving teicoplanin as part of routine clinical care.
meropenem
Patients receiving meropenem as part of routine clinical care.
ciprofloxacin
Patients receiving ciprofloxacin as part of routine clinical care.
amikacin
Patients receiving amikcain as part of routine clinical care.
Interventions
Eligibility Criteria
children admitted to a neonatal or pediatric intensive care unit
You may qualify if:
- 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)
You may not qualify if:
- 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 )
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ghent University Hospital, Hospital Pharmacy
Ghent, 9000, Belgium
Related Publications (5)
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.
PMID: 40239747DERIVEDVan 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: 35426861DERIVEDAulin 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: 33030704DERIVEDDe 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: 27999035DERIVEDDe 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: 26349821DERIVED
Biospecimen
blood samples and urine samples (only for ciprofloxacin)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pieter De Cock
University Hospital, Ghent
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Days
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2015
First Posted
May 29, 2015
Study Start
May 1, 2012
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
January 16, 2026
Record last verified: 2026-01