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Recruiting NCT06426836

Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)

No phase Interventional Pharmacokinetics Amoxicillin-clavulanate Piperacillin-tazobactam Meropenem

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem, Cefazolin.
Who it may be relevant to
Registry conditions: Pharmacokinetics, Amoxicillin-clavulanate, Piperacillin-tazobactam, Meropenem. Basic parameters: up to 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation

Overview

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

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.

Interventions

  • Other Amoxicillin-clavulanate
    blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care
  • Other Piperacillin-tazobactam
    blood sampling in patients receiving piperacillin-tazobactam as part of routine clinical care.
  • Other Meropenem
    blood sampling in patients receiving meropenem as part of routine clinical care.
  • Other Cefazolin
    blood sampling in patients receiving cefazolin as part of routine clinical care.
  • Other Vancomycin
    blood sampling in patients receiving vancomycin as part of routine clinical care.
  • Other Teicoplanin
    blood sampling in patients receiving teicoplanin as part of routine clinical care.
  • Other Ciprofloxacin
    blood sampling and urine sampling in patients receiving ciprofloxacin as part of routine clinical care.
  • Other Amikacin
    blood sampling in patients receiving amikacin as part of routine clinical care.

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
Secondary outcome measures (11)
  • Risk factors for underdosing during extracorporeal membrane oxygenation for beta-lactam antibiotics [Time frame: up to 1 month]
  • Risk factors for underdosing during extracorporeal membrane oxygenation for ciprofloxacin [Time frame: up to 1 month]
  • Risk factors for under-and overdosing during extracorporeal membrane oxygenation for vancomycin [Time frame: up to 1 month]
  • Risk factors for underdosing during extracorporeal membrane oxygenation for teicoplanin [Time frame: up to 1 month]
  • Risk factors for under-and overdosing during extracorporeal membrane oxygenation for amikacin [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: up to 1 month]
  • Teicoplanin: probability of target attainment with the target being a mimimal trough concentration [Time frame: up to 1 month]
  • 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]
  • Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration [Time frame: up to 1 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Belgium · 3 centers
  • Queen Fabiola Children's University Hospital — Brussels
  • University Hospital — Ghent
  • Universitair hospital — Leuven

Identifiers

NCT: NCT06426836 · EC 2015/0529

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗