Clinical trial NCT06426836: Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)
Official title: Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pharmacokinetics
Amoxicillin-clavulanate
Piperacillin-tazobactam
Meropenem
Cefazolin
Teicoplanin
Vancomycin
Ciprofloxacin
Amikacin
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 300
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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

Primary outcomes:
measure: 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
timeFrame: up to 1 month
measure: 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
timeFrame: up to 1 month
measure: 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
timeFrame: up to 1 month
measure: 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
timeFrame: up to 1 month
measure: 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
timeFrame: up to 1 month
measure: 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
timeFrame: up to 1 month
measure: 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
timeFrame: up to 1 month
measure: 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
timeFrame: up to 1 month
measure: Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC)
timeFrame: up to 1 month
measure: Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC)
timeFrame: up to 1 month
measure: Teicoplanin: probability of target attainment with the target being a mimimal trough concentration
timeFrame: up to 1 month
measure: for teicoplanin: probability of target attainment with the target being an Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration Ratio (AUC/MIC)
timeFrame: up to 1 month
measure: for amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC)
timeFrame: up to 1 month
measure: Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration
timeFrame: up to 1 month
measure: Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration
timeFrame: up to 1 month
measure: Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC)
timeFrame: July 2026
measure: Amikacin: probability of target attainment with the target being a free Area-under-the-Concentration-Time Curve over Minimal Inhibitory Concentration ratio (AUC/MIC)
timeFrame: July 2026
Secondary outcomes:
measure: Risk factors for underdosing during extracorporeal membrane oxygenation for beta-lactam antibiotics
timeFrame: up to 1 month
measure: Risk factors for underdosing during extracorporeal membrane oxygenation for ciprofloxacin
timeFrame: up to 1 month
measure: Risk factors for under-and overdosing during extracorporeal membrane oxygenation for vancomycin
timeFrame: up to 1 month
measure: Risk factors for underdosing during extracorporeal membrane oxygenation for teicoplanin
timeFrame: up to 1 month
measure: Risk factors for under-and overdosing during extracorporeal membrane oxygenation for amikacin
timeFrame: up to 1 month
measure: 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)
timeFrame: up to 1 month
measure: Ciprofloxacin: probability of target attainment with the target being the free Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration ratio (fAUC/MIC)
timeFrame: up to 1 month
measure: Vancomycin: probability of target attainment with the target being the Area-under the Concentration-Time Curve over Minimal Inhibitory Concentration (AUC/MIC)
timeFrame: up to 1 month
measure: Teicoplanin: probability of target attainment with the target being a mimimal trough concentration
timeFrame: up to 1 month
measure: Amikacin: probability of target attainment with the target being a peak concentration over Minimal Inhibitory Concentration ratio (peak/MIC)
timeFrame: up to 1 month
measure: Amikacin: probability of toxicity threshold attainment with a target being a minimal trough concentration
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Queen Fabiola Children's University Hospital
city: Ghent
country: Belgium
facility: University Hospital
city: Leuven
country: Belgium
facility: Universitair hospital
Study officials:
affiliation: University Hospital, Ghent
name: Annick de Jaeger, MD
role: PRINCIPAL_INVESTIGATOR
References: