About this trial
Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
no catheter in place for blood sampling
absence of parental/patient consent
known hypersensitivity to beta-lactam antibiotics and ciprofloxacin
Trial design
Parallel
Treatments tested in this trial
Amoxicillin-clavulanate
Other interventionblood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care
Piperacillin-tazobactam
Other interventionblood sampling in patients receiving piperacillin-tazobactam as part of routine clinical care.
Meropenem
Other interventionblood sampling in patients receiving meropenem as part of routine clinical care.
Cefazolin
Other interventionblood sampling in patients receiving cefazolin as part of routine clinical care.
Vancomycin
Other interventionblood sampling in patients receiving vancomycin as part of routine clinical care.
Teicoplanin
Other interventionblood sampling in patients receiving teicoplanin as part of routine clinical care.
Ciprofloxacin
Other interventionblood sampling and urine sampling in patients receiving ciprofloxacin as part of routine clinical care.
Amikacin
Other interventionblood sampling in patients receiving amikacin as part of routine clinical care.
Treatment groups
8
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
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
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
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
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
Secondary outcomes
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
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
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
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
Sponsors and contacts
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