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NCT Number: NCT06426836

Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)

Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO).

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Key information

Conditions

Pharmacokinetics Amikacin Amoxicillin-clavulanate Cefazolin Ciprofloxacin Meropenem Piperacillin-tazobactam Teicoplanin Vancomycin

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Fabiola Children's University Hospital, Brussels, Brussels Capital, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • no catheter in place for blood sampling
  • absence of parental/patient consent
  • known hypersensitivity to beta-lactam antibiotics and ciprofloxacin

Treatment and study plan

Amoxicillin-clavulanate

Other

blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care

Other names: Blood sampling

Piperacillin-tazobactam

Other

blood sampling in patients receiving piperacillin-tazobactam as part of routine clinical care.

Other names: Blood sampling

Meropenem

Other

blood sampling in patients receiving meropenem as part of routine clinical care.

Other names: Blood sampling

Cefazolin

Other

blood sampling in patients receiving cefazolin as part of routine clinical care.

Other names: Blood sampling

Vancomycin

Other

blood sampling in patients receiving vancomycin as part of routine clinical care.

Other names: Blood sampling

Teicoplanin

Other

blood sampling in patients receiving teicoplanin as part of routine clinical care.

Other names: Blood sampling

Ciprofloxacin

Other

blood sampling and urine sampling in patients receiving ciprofloxacin as part of routine clinical care.

Other names: Blood sampling

Amikacin

Other

blood sampling in patients receiving amikacin as part of routine clinical care.

Other names: Blood sampling

Primary outcomes

  1. 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

    Time frame: up to 1 month

    % 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

  2. 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

    Time frame: up to 1 month

    % 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

  3. 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

    Time frame: up to 1 month

    % 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

  4. 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

    Time frame: up to 1 month

    % 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

  5. 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

    Time frame: up to 1 month

    % 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

  6. 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

    Time frame: up to 1 month

    % 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

  7. 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

    Time frame: up to 1 month

    % 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

  8. 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

    Time frame: up to 1 month

    % 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

  9. Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC)

    Time frame: up to 1 month

    % of patients for whom a fAUC/MIC target>86 is achieved with the current dosing regimen off extracorporeal membrane oxygenation in steady-state conditions

  10. Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC)

    Time frame: up to 1 month

    % 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

  11. Teicoplanin: probability of target attainment with the target being a mimimal trough concentration

    Time frame: up to 1 month

    % 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

  12. for teicoplanin: probability of target attainment with the target being an Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration Ratio (AUC/MIC)

    Time frame: up to 1 month

    % 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

  13. for amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC)

    Time frame: up to 1 month

    % 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

  14. Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration

    Time frame: up to 1 month

    % 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

  15. Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration

    Time frame: up to 1 month

    % 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

  16. Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC)

    Time frame: July 2026

    % 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

  17. Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC)

    Time frame: July 2026

    % 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

Secondary outcomes

  1. Risk factors for underdosing during extracorporeal membrane oxygenation for beta-lactam antibiotics

    Time frame: up to 1 month

    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

  2. Risk factors for underdosing during extracorporeal membrane oxygenation for ciprofloxacin

    Time frame: up to 1 month

    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

  3. Risk factors for under-and overdosing during extracorporeal membrane oxygenation for vancomycin

    Time frame: up to 1 month

    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

  4. Risk factors for underdosing during extracorporeal membrane oxygenation for teicoplanin

    Time frame: up to 1 month

    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

  5. Risk factors for under-and overdosing during extracorporeal membrane oxygenation for amikacin

    Time frame: up to 1 month

    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

  6. 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)

    Time frame: up to 1 month

    % 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

  7. Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC)

    Time frame: up to 1 month

    % of patients for whom a fAUC/MIC target>86 is achieved with the current dosing regimen on extracorporeal membrane oxygenation in first-dose conditions

  8. Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC)

    Time frame: up to 1 month

    % 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

  9. Teicoplanin: probability of target attainment with the target being a mimimal trough concentration

    Time frame: up to 1 month

    % 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

  10. Amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC)

    Time frame: up to 1 month

    % 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

  11. Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration

    Time frame: up to 1 month

    % 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

Study contacts

Contact information is provided by the study sponsor or research team.

Pieter De Cock, PharmD

CONTACT

[email protected]

+32 9 332 29 69

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation

Acronym: PADECMO

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
May 23, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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