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Completed

NCT Number: NCT02993575

Pharmacokinetics of Flucloxacillin Given by Continuous or Intermittent Infusion to ICU Patients

The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared to non-ICU patients. The investigators will determine total and free flucloxacillin concentrations in 30 ICU patients, who will get continuous (n=10) or intermittent infusion (n=20) of flucloxacillin as standard care.

Full pharmacokinetic curves will be taken for individual patients on the intermittent dosing regimen and limited sampling will be taken for individual patients on the continuous dosing regimen on day 2 and 4.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud University Medical Center

Nijmegen, Netherlands

About this study

The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared to non-ICU patients. There is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU. To prevent the risk of inadequate dosing in critically ill patients, it is important to optimize dosing regimens in ICU patients.

With this study the investigators will define pharmacokinetics of flucloxacillin in ICU patients and search for variables influencing pharmacokinetics. By using population modeling the investigators will simulate different dosing regimens, intermittent and continuous, and compare probability of target attainment between continuous and intermittent infusion.

To be able to include 30 patients within the study duration, a multi-centre approach is necessary.

Patients will receive standard care, as stated in the product characteristics or according to local protocols. Minimally invasive blood sampling for pharmacokinetic analysis will be retrieved through a central venous catheter or an arterial line. Full pharmacokinetic curves will be taken for individual patients on the intermittent dosing regimen and limited sampling will be taken for individual patients on the continuous dosing regimen on day 2 and 4.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is admitted to an ICU
  • Subject is at least 18 years old on the day of the first dosing
  • Is managed with a central venous catheter or arterial line
  • Patient is treated with flucloxacillin

Exclusion criteria

  • Has previously participated in this trial

Treatment and study plan

Flucloxacillin

Drug

Dose according to summary of product characteristics (SPC) or local protocols: intermittent and continuous infusion

Other names: Floxapen

Primary outcomes

  1. Clearance

    Time frame: Day 2 and 4

    Full pharmacokinetic curves will be taken on Day 2 and Day 4

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Canisius-Wilhelmina Hospital
  • Gelderse Vallei Hospital
  • Rijnstate Hospital
  • Tergooi Hospital
  • UMC Utrecht

Registry information

Official study title

Pharmacokinetics of Flucloxacillin Given by Continuous or Intermittent Infusion as Therapy to Patients With an Infection in the Intensive Care Unit (ICU)

Acronym: FANATIC

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2016
Registry last updated
Oct 23, 2018

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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