PharmacokineticsADICNCT02456974
Antibiotic Dosing in Pediatric Intensive Care
An observational study of Pharmacokinetics and Amoxicillin-clavulanate, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Pharmacokinetics of antibiotics in critically ill neonates, infants and children Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Pharmacokinetics, Amoxicillin-clavulanate, Piperacillin-tazobactam
- What is being tested?
- 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. and blood sampling in patients receiving vancomycin as part of routine clinical care.
- Type of treatment
- Surgery or procedure
- How many people
- 640 participants
- Where
- 1 siteBelgium
- Study dates
- May 2012to 1 Sep 2027
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: children admitted to a neonatal or pediatric intensive care unit
Who may be able to join
- 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)
Who cannot join
- 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 )
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital, Hospital Pharmacy
Ghent, 9000
Pieter De Cock, PharmD, +3293322969, pieter.decock@uzgent.be
Pieter De Cock, PharmD
About this study
Pharmacokinetics of antibiotics in critically ill neonates, infants and children
- Conditions
- Pharmacokinetics, Amoxicillin-clavulanate, Piperacillin-tazobactam, Vancomycin, Teicoplanin, Meropenem
- Being tested
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical careProcedure or surgery
blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care.Procedure or surgery
blood sampling in patients receiving vancomycin as part of routine clinical care.Procedure or surgery
blood sampling in patients receiving teicoplanin as part of routine clinical care.Procedure or surgery
blood sampling in patients receiving meropenem as part of routine clinical care.Procedure or surgery
blood sampling and urine smapling in patients receiving ciprofloxacin as part of routine clinical care.Procedure or surgery
blood sampling in patients receiving amikacin as part of routine clinical care.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| amoxicillin-clavulanate | Patients receiving amoxicillin-clavulanate as part of routine clinical care. Receives: Procedure: 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. Receives: Procedure: blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care. | |
| vancomycin | Patients receiving vancomycin as part of routine clinical care. Receives: Procedure: blood sampling in patients receiving vancomycin as part of routine clinical care. | |
| teicoplanin | Patients receiving teicoplanin as part of routine clinical care. Receives: Procedure: blood sampling in patients receiving teicoplanin as part of routine clinical care. | |
| meropenem | Patients receiving meropenem as part of routine clinical care. Receives: Procedure: blood sampling in patients receiving meropenem as part of routine clinical care. | |
| ciprofloxacin | Patients receiving ciprofloxacin as part of routine clinical care. Receives: Procedure: 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. Receives: Procedure: blood sampling in patients receiving amikacin as part of routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate if first-dose blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens.
Measured: 2 years (expected)
To investigate if steady-state blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens.
Measured: 2 years (expected)
Secondary outcomes (2)
To compare measured first-dose blood concentrations with predefined pharmacodynamic targets (Time above MIC)
Measured: 2 years (expected)
To compare measured steady-state blood concentrations with predefined pharmacodynamic targets (Time above MIC)
Measured: 2 years (expected)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMay 2012
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 640 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, Queen Fabiola Children's University Hospital (HUDERF/UKZKF)
- Responsible party
- Sponsor
- Investigators
- Pieter De Cock, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456974
- Sponsor's protocol ID
- BC-00828 (EC 2012/172)
- Acronym
- ADIC
- Status last verified
- Sep 2026
- First submitted
- 18 May 2015
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
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. Epub 2025 Apr 15.
PubMed 40239747Van 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.
PubMed 35426861Aulin 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.
PubMed 33030704De 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.
PubMed 27999035De 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.
PubMed 26349821
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Dosing in Pediatric Intensive Care
- ClinicalTrials.gov ID
- NCT02456974
- Acronym / sponsor ID
- ADIC / BC-00828 (EC 2012/172)
- Conditions
- Pharmacokinetics, Amoxicillin-clavulanate, Piperacillin-tazobactam, Vancomycin, Teicoplanin, Meropenem
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, Queen Fabiola Children's University Hospital (HUDERF/UKZKF)
- Study start
- May 2012
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pharmacokinetics of antibiotics in critically ill neonates, infants and children
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| amoxicillin-clavulanate | – | Procedure: blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical carePatients receiving amoxicillin-clavulanate as part of routine clinical care. |
| piperacilline-tazobactam | – | Procedure: blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care.Patients receiving piperacilline-tazobactam as part of routine clinical care. |
| vancomycin | – | Procedure: blood sampling in patients receiving vancomycin as part of routine clinical care.Patients receiving vancomycin as part of routine clinical care. |
| teicoplanin | – | Procedure: blood sampling in patients receiving teicoplanin as part of routine clinical care.Patients receiving teicoplanin as part of routine clinical care. |
| meropenem | – | Procedure: blood sampling in patients receiving meropenem as part of routine clinical care.Patients receiving meropenem as part of routine clinical care. |
| ciprofloxacin | – | Procedure: blood sampling and urine smapling in patients receiving ciprofloxacin as part of routine clinical care.Patients receiving ciprofloxacin as part of routine clinical care. |
| amikacin | – | Procedure: blood sampling in patients receiving amikacin as part of routine clinical care.Patients receiving amikcain as part of routine clinical care. |
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children admitted to a neonatal or pediatric intensive care unit
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care | Procedure or surgery | amoxicillin-clavulanate |
| blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care. | Procedure or surgery | piperacilline-tazobactam |
| blood sampling in patients receiving vancomycin as part of routine clinical care. | Procedure or surgery | vancomycin |
| blood sampling in patients receiving teicoplanin as part of routine clinical care. | Procedure or surgery | teicoplanin |
| blood sampling in patients receiving meropenem as part of routine clinical care. | Procedure or surgery | meropenem |
| blood sampling and urine smapling in patients receiving ciprofloxacin as part of routine clinical care. | Procedure or surgery | ciprofloxacin |
| blood sampling in patients receiving amikacin as part of routine clinical care. | Procedure or surgery | amikacin |
Primary outcome
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)
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Derived from this study: PubMed 40239747Dhont 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.
- Derived from this study: PubMed 35426861Van 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.
- Derived from this study: PubMed 33030704Aulin 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.
- Derived from this study: PubMed 27999035De 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.
- Derived from this study: PubMed 26349821De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pieter De Cock principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacokinetics and Amoxicillin-clavulanate, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pieter De Cock, PharmD (+32 9 332 29 69, pieter.decock@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate if first-dose blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens. (time frame: 2 years (expected)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02456974, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.