Antibiotic Dosing in Pediatric Intensive Care

Study Overview
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Brief Summary
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Pharmacokinetics of antibiotics in critically ill neonates, infants and children

Official Title
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Antibiotic Dosing in Pediatric Intensive Care

Conditions
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Pharmacokinetics, Amoxicillin-clavulanate, Piperacillin-tazobactam, Vancomycin, Teicoplanin, Meropenem, Ciprofloxacin, Amikacin

Intervention / Treatment
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* Procedure: blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care
* Procedure: blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care.
* Procedure: blood sampling in patients receiving vancomycin as part of routine clinical care.
* Procedure: blood sampling in patients receiving teicoplanin as part of routine clinical care.
* Procedure: blood sampling in patients receiving meropenem as part of routine clinical care.
* Procedure: blood sampling and urine smapling in patients receiving ciprofloxacin as part of routine clinical care.
* Procedure: blood sampling in patients receiving amikacin as part of routine clinical care.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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 )

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| amoxicillin-clavulanate<br>Patients receiving amoxicillin-clavulanate as part of routine clinical care. | Procedure: blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care<br> <br> |
| piperacilline-tazobactam<br>Patients receiving piperacilline-tazobactam as part of routine clinical care. | Procedure: blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care.<br> <br> |
| vancomycin<br>Patients receiving vancomycin as part of routine clinical care. | Procedure: blood sampling in patients receiving vancomycin as part of routine clinical care.<br> <br> |
| teicoplanin<br>Patients receiving teicoplanin as part of routine clinical care. | Procedure: blood sampling in patients receiving teicoplanin as part of routine clinical care.<br> <br> |
| meropenem<br>Patients receiving meropenem as part of routine clinical care. | Procedure: blood sampling in patients receiving meropenem as part of routine clinical care.<br> <br> |
| ciprofloxacin<br>Patients receiving ciprofloxacin as part of routine clinical care. | Procedure: blood sampling and urine smapling in patients receiving ciprofloxacin as part of routine clinical care.<br> <br> |
| amikacin<br>Patients receiving amikcain as part of routine clinical care. | Procedure: blood sampling in patients receiving amikacin as part of routine clinical care.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate if first-dose blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens. |  | 2 years (expected) | 
| To investigate if steady-state blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens. |  | 2 years (expected) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare measured first-dose blood concentrations with predefined pharmacodynamic targets (Time above MIC) |  | 2 years (expected) | 
| To compare measured steady-state blood concentrations with predefined pharmacodynamic targets (Time above MIC) |  | 2 years (expected) |