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Antibiotic Dosing in Pediatric Intensive Care

Information source: University Hospital, Ghent
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics; Amoxicillin-clavulanate; Piperacillin-tazobactam

Intervention: blood sampling (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: University Hospital, Ghent

Overall contact:
Pieter De Cock, PharmD, Phone: +32 9 332 29 69, Email: pieter.decock@uzgent.be

Summary

Pharmacokinetics of antibiotics in critically ill neonates, infants and children

Clinical Details

Official title: Antibiotic Dosing in Pediatric Intensive Care

Study design: Time Perspective: Prospective

Primary outcome:

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

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

Secondary outcome:

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

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

Eligibility

Minimum age: N/A. Maximum age: 16 Years. Gender(s): Both.

Criteria:

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) via intermittent infusion regimen 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 or glycopeptides

- extracorporeal circuit (haemodialysis, ECMO, peritoneal dialysis )

Locations and Contacts

Pieter De Cock, PharmD, Phone: +32 9 332 29 69, Email: pieter.decock@uzgent.be

Ghent University Hospital, Hospital Pharmacy, Ghent 9000, Belgium; Recruiting
Pieter De Cock, PharmD, Phone: +3293322969, Email: pieter.decock@uzgent.be
Pieter De Cock, PharmD, Sub-Investigator
Annick de Jaeger, MD, Principal Investigator
Dominique Biarent, MD, Principal Investigator
Jozef De Dooy, MD, Principal Investigator
Additional Information

Starting date: May 2012
Last updated: May 26, 2015

Page last updated: August 23, 2015

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