Antibiotic Dosing in Pediatric Intensive Care (ADIC)

December 14, 2023 updated by: University Hospital, Ghent
Pharmacokinetics of antibiotics in critically ill neonates, infants and children

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

640

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • Ghent University Hospital, Hospital Pharmacy
        • Contact:
        • Principal Investigator:
          • Pieter De Cock, PharmD
        • Principal Investigator:
          • Annick de Jaeger, MD
        • Principal Investigator:
          • Dominique Biarent, MD
        • Principal Investigator:
          • Jozef De Dooy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children admitted to a neonatal or pediatric intensive care unit

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
amoxicillin-clavulanate
Patients receiving amoxicillin-clavulanate as part of routine clinical care.
Procedure: blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care
piperacilline-tazobactam
Patients receiving piperacilline-tazobactam as part of routine clinical care.
Procedure: blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care.
vancomycin
Patients receiving vancomycin as part of routine clinical care.
Procedure: blood sampling in patients receiving vancomycin as part of routine clinical care.
teicoplanin
Patients receiving teicoplanin as part of routine clinical care.
Procedure: blood sampling in patients receiving teicoplanin as part of routine clinical care.
meropenem
Patients receiving meropenem as part of routine clinical care.
Procedure: blood sampling in patients receiving meropenem as part of routine clinical care.
ciprofloxacin
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.
amikacin
Patients receiving amikcain as part of routine clinical care.
Procedure: blood sampling in patients receiving amikacin as part of routine clinical care.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

University Hospital, Antwerp
Queen Fabiola Children's University Hospital, Brussels

Investigators

  • Principal Investigator: Pieter De Cock, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

April 28, 2025

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimated)

May 29, 2015

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/172

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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