Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 15
SponsorUniversity Hospital, Ghent

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Amoxicillin-clavulanate

    Other intervention

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

  • Piperacillin-tazobactam

    Other intervention

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

  • Meropenem

    Other intervention

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

  • Cefazolin

    Other intervention

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

  • Vancomycin

    Other intervention

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

  • Teicoplanin

    Other intervention

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

  • Ciprofloxacin

    Other intervention

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

  • Amikacin

    Other intervention

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

Treatment groups

300 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Amoxicillin-clavulanateOther 1 intervention
Group B: Piperacillin-tazobactamOther 1 intervention
Group C: MeropenemOther 1 intervention
Group D: CefazolinOther 1 intervention
Group E: VancomycinOther 1 intervention
Group F: TeicoplaninOther 1 intervention
Group G: CiprofloxacinOther 1 intervention
Group H: AmikacinOther 1 intervention

Trial outcomes

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

% 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

Time frame
up to 1 month
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

% 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

Time frame
up to 1 month
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

% 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

Time frame
up to 1 month
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

% 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

Time frame
up to 1 month

Secondary outcomes

1

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

Time frame
up to 1 month
2

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

Time frame
up to 1 month
3

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

Time frame
up to 1 month
4

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

Time frame
up to 1 month

Other outcomes

Sponsors and contacts

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