PharmacokineticsPADECMONCT06426836
Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)
A study testing Amoxicillin-clavulanate, Piperacillin-tazobactam and Meropenem in people with Pharmacokinetics and Amoxicillin-clavulanate, run by University Hospital, Ghent at 3 sites in Belgium.
Trial summary
Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO). Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Pharmacokinetics, Amoxicillin-clavulanate, Piperacillin-tazobactam
- What is being tested?
- Amoxicillin-clavulanate, Piperacillin-tazobactam and Meropenem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesBelgium
- Study dates
- 19 Aug 2016to 1 Jul 2029
- Phase
- Interventional
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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients admitted to the pediatric intensive care unit or cardiac intensive care unit
- patient age : 1,8 kg-15 years
- patient receiving antibiotic treatment (piperacillin-tazobactam, meropenem, amoxicillin-clavulanate, cephazolin, vancomycin, teicoplanin, ciprofloxacin, amikacin)
- intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred)
- extracorporeal membrane oxygenation circuit
Who cannot join
- no catheter in place for blood sampling
- absence of parental/patient consent
- known hypersensitivity to beta-lactam antibiotics and ciprofloxacin
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites, 3 recruiting
- Recruiting
Queen Fabiola Children's University Hospital
Brussels, Brussels Capital, 1020
Biarent Dominique, dominique.biarent@huderf.be
Vens Daphne, daphnevania.vens@huderf.be
- Recruiting
University Hospital
Ghent, 9000
Pieter De Cock, pieter.decock@uzgent.be
- Recruiting
Universitair hospital
Leuven, 3000
Debaveye Yves, yves.debaveye@uzleuven.be
About this study
Official title: Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation
Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO).
Read the detailed description
The study will investigate whether - with the current dosing regimens of meropenem, piperacillin-tazobactam, amoxicillin-clavulanate, cephazolin, vancomycin, amikacin, teicoplanin and ciprofloxacin - pharmacodynamic targets are attained in a national multicentric clinical setting in pediatric patients on ECMO.
- Conditions
- Pharmacokinetics, Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem, Cefazolin, Teicoplanin
- Being tested
- Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem, Cefazolin, Vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-clavulanateOther
Also called Blood sampling
blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care
Piperacillin-tazobactamOther
Also called Blood sampling
blood sampling in patients receiving piperacillin-tazobactam as part of routine clinical care.
MeropenemOther
Also called Blood sampling
blood sampling in patients receiving meropenem as part of routine clinical care.
CefazolinOther
Also called Blood sampling
blood sampling in patients receiving cefazolin as part of routine clinical care.
VancomycinOther
Also called Blood sampling
blood sampling in patients receiving vancomycin as part of routine clinical care.
TeicoplaninOther
Also called Blood sampling
blood sampling in patients receiving teicoplanin as part of routine clinical care.
CiprofloxacinOther
Also called Blood sampling
blood sampling and urine sampling in patients receiving ciprofloxacin as part of routine clinical care.
AmikacinOther
Also called Blood sampling
blood sampling in patients receiving amikacin as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin-clavulanate | Other | Patients receiving amoxicillin-clavulanate as part of routine clinical care. Study procedure: blood sampling Receives: Other: Amoxicillin-clavulanate |
| Piperacillin-tazobactam | Other | Patients receiving piperacillin-tazobactam as part of routine clinical care. Study procedure: blood sampling Receives: Other: Piperacillin-tazobactam |
| Meropenem | Other | Patients receiving meropenem as part of routine clinical care. Study procedure: blood sampling Receives: Other: Meropenem |
| Cefazolin | Other | Patients receiving cefazolin as part of routine clinical care. Study procedure: blood sampling Receives: Other: Cefazolin |
| Vancomycin | Other | Patients receiving vancomycin as part of routine clinical care. Study procedure: blood sampling Receives: Other: Vancomycin |
| Teicoplanin | Other | Patients receiving teicoplanin as part of routine clinical care. Study procedure: blood sampling Receives: Other: Teicoplanin |
| Ciprofloxacin | Other | Patients receiving ciprofloxacin as part of routine clinical care. Study procedure: blood sampling Receives: Other: Ciprofloxacin |
| Amikacin | Other | Patients receiving amikacin as part of routine clinical care. Study procedure: blood sampling Receives: Other: Amikacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amoxicillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
% of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
Cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
% of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
Meropenem: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
% of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
Piperacillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
% of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
Amoxicillin, piperacillin, meropenem, cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
% of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
Cefazolin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
% of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
Meropenem: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
% of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
Piperacillin: probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC) of the micro-organism
% of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens before or after extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC)
% of patients for whom a fAUC/MIC target>86 is achieved with the current dosing regimen off extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC)
% of patients in whom a AUC/MIC target 400-600 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
Teicoplanin: probability of target attainment with the target being a mimimal trough concentration
% of patients in whom a trough concentration between 20 to 30 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
for teicoplanin: probability of target attainment with the target being an Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration Ratio (AUC/MIC)
% of patients in whom an AUC/MIC of 900 is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
for amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC)
% of patients in whom a target peak/MIC ratio of 8 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration
% of patients in whom the threshold for toxicity concentration>5 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration
% of patients in whom the threshold for toxicity concentration>5 mg/L is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions
Measured: up to 1 month
Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC)
% of patients in whom a target fAUC/MIC ratio of 399 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in steady-state conditions
Measured: July 2026
Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC)
% of patients in whom a target fAUC/MIC ratio of 399 is achieved with the current dosing regimen before or after extracorporeal membrane oxygenation in steady-state conditions
Measured: July 2026
Secondary outcomes (11)
Risk factors for underdosing during extracorporeal membrane oxygenation for beta-lactam antibiotics
The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a percentage of time during which the unbound concentration remains above the Minimal Inhibitory Concentration (MIC) of the micro-organism of at least 50% and a maximum concentration of 10 x MIC
Measured: up to 1 month
Risk factors for underdosing during extracorporeal membrane oxygenation for ciprofloxacin
The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of ciprofloxacin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a free Area-under the concentration-Time Curve of 86
Measured: up to 1 month
Risk factors for under-and overdosing during extracorporeal membrane oxygenation for vancomycin
The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of vancomycin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a free Area-under the concentration-Time Curve of 200 to 300
Measured: up to 1 month
Risk factors for underdosing during extracorporeal membrane oxygenation for teicoplanin
The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of teicoplanin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is an Area-under the concentration-Time Curve of 900
Measured: up to 1 month
Risk factors for under-and overdosing during extracorporeal membrane oxygenation for amikacin
The impact of demographic, clinical characteristics and ECMO equipment characteristics on the risk of underdosing and overdosing of amikacin will be investigated. The pharmacokinetic/pharmacodynamic target that is used is a peak over Minimal Inhibitory Concentration Ratio of 8 to 10, trough concentration below 5 mg/L and Area under the Concentration Time Curve/MIC>399
Measured: up to 1 month
Beta-lactam antibiotics (amoxicillin, piperacillin, meropenem, cefazolin): probability of target attainment with target the % of time during which the unbound drug concentration remains above the Minimal Inhibitory Concentration (fT>MIC)
% of patients for whom a target of fT>MIC of 50% is achieved with current dosing regimens on extracorporeal membrane oxygenation in first dose conditions
Measured: up to 1 month
Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC)
% of patients for whom a fAUC/MIC target>86 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions
Measured: up to 1 month
Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC)
% of patients in whom a AUC/MIC target 400-600 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions
Measured: up to 1 month
Teicoplanin: probability of target attainment with the target being a mimimal trough concentration
% of patients in whom a trough concentration between 20 to 30 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions
Measured: up to 1 month
Amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC)
% of patients in whom a target peak/MIC ratio of 8 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions
Measured: up to 1 month
Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration
% of patients in whom the threshold for toxicity concentration>5 mg/L is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start19 Aug 2016
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annick de Jaeger, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426836
- Sponsor's protocol ID
- BC-03512 (EC 2015/0529)
- Acronym
- PADECMO
- Status last verified
- Sep 2026
- First submitted
- 13 May 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided