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NCT02456974 Clinical Trial

Antibiotic Dosing in Pediatric Intensive Care

Pharmacokinetics Clinical Trial

— ADIC  

Official title:
Antibiotic Dosing in Pediatric Intensive Care

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02456974
Other study ID # 2012/172
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2012
Est. completion date April 28, 2025

Study information
Verified date December 2023
Source University Hospital, Ghent
Contact Pieter De Cock, PharmD
Phone +32 9 332 29 69
Email pieter.decock@uzgent.be
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Pharmacokinetics of antibiotics in critically ill neonates, infants and children

Recruitment information / eligibility
Status Recruiting
Enrollment 640
Est. completion date April 28, 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 1 Day to 16 Years
Eligibility 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 )

Study Design

Related Conditions & MeSH terms

Intervention

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

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

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

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

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

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

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

Locations
Country Name City State
Belgium Ghent University Hospital, Hospital Pharmacy Ghent

Sponsors (3)
Lead Sponsor Collaborator
University Hospital, Ghent Queen Fabiola Children's University Hospital, Brussels, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary To investigate if first-dose blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens. 2 years (expected)
Primary To investigate if steady-state blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens. 2 years (expected)
Secondary To compare measured first-dose blood concentrations with predefined pharmacodynamic targets (Time above MIC) 2 years (expected)
Secondary To compare measured steady-state blood concentrations with predefined pharmacodynamic targets (Time above MIC) 2 years (expected)
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