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Recruiting

NCT Number: NCT02456974

Antibiotic Dosing in Pediatric Intensive Care

Pharmacokinetics of antibiotics in critically ill neonates, infants and children

Recruiting

Interested in participating?

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Key information

Conditions

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

Age range

1 day–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital, Hospital Pharmacy

Ghent, 9000, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

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.

Procedure

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)

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

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

Registry information

Acronym: ADIC

Important dates

Study start
2012
Primary completion
2027
Study completion
2027
First posted
May 29, 2015
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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