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

R

Radboud University Medical Center

Status

Completed

Conditions

Bacterial Infections

Treatments

Drug: Flucloxacillin

Study type

Observational

Funder types

Other

Identifiers

NCT02993575
UMCN-AKF-16.08

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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