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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02993575

Acronym

FANATIC

Enrollment

Registered

2016-12-15

Start date

2017-06-01

Completion date

2018-04-01

Last updated

2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections

Keywords

Pharmacokinetics, Flucloxacillin, Continuous infusion, Intensive Care Unit

Brief summary

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.

Detailed description

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.

Interventions

DRUGFlucloxacillin

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient is admitted to an ICU 2. Subject is at least 18 years old on the day of the first dosing 3. Is managed with a central venous catheter or arterial line 4. Patient is treated with flucloxacillin

Exclusion criteria

1\. Has previously participated in this trial

Design outcomes

Primary

Measure	Time frame	Description
Clearance	Day 2 and 4	Full pharmacokinetic curves will be taken on Day 2 and Day 4

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026