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Antibiotic Dosing in Pediatric Intensive Care

ConditionsPharmacokineticsAmoxicillin-clavulanatePiperacillin-tazobactamVancomycinTeicoplaninMeropenemCiprofloxacinAmikacin
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-16
SponsorUniversity Hospital, Ghent

About this trial

Pharmacokinetics of antibiotics in critically ill neonates, infants and children

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients admitted to the pediatric intensive care unit

patient age/weight : 1,8 kg-15 years

patient receiving antibiotic treatment (piperacillin-tazobactam, amoxicillin-clavulanate, vancomycin, teicoplanin, meropenem, ciprofloxacin, amikacin) via intermittent infusion regimen or continuous infusion according to institutional treatment guidelines

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, glycopeptides, fluoroquinolones, aminoglycosides

extracorporeal circuit (haemodialysis, ECMO, peritoneal dialysis )

Trial population

children admitted to a neonatal or pediatric intensive care unit

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

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

    Procedure/Surgery

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

    Procedure/Surgery

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

    Procedure/Surgery

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

    Procedure/Surgery

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

    Procedure/Surgery

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

    Procedure/Surgery

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

    Procedure/Surgery

Treatment groups

640 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: amoxicillin-clavulanate1 intervention
Group B: piperacilline-tazobactam1 intervention
Group C: vancomycin1 intervention
Group D: teicoplanin1 intervention
Group E: meropenem1 intervention
Group F: ciprofloxacin1 intervention
Group G: amikacin1 intervention

Trial outcomes

Primary outcomes

1

To investigate if first-dose blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens.

Time frame
2 years (expected)
2

To investigate if steady-state blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens.

Time frame
2 years (expected)

Secondary outcomes

1

To compare measured first-dose blood concentrations with predefined pharmacodynamic targets (Time above MIC)

Time frame
2 years (expected)
2

To compare measured steady-state blood concentrations with predefined pharmacodynamic targets (Time above MIC)

Time frame
2 years (expected)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

University Hospital, Antwerp

Collaborator

Queen Fabiola Children's University Hospital (HUDERF/UKZKF)

Collaborator

Source ClinicalTrials.gov
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