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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02993575
Other study ID # UMCN-AKF-16.08
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2017
Est. completion date April 1, 2018

Study information

Verified date October 2018
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 1, 2018
Est. primary completion date March 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands Radboud University Medical Center Nijmegen

Sponsors (6)

Lead Sponsor Collaborator
Radboud University Canisius-Wilhelmina Hospital, Gelderse Vallei Hospital, Rijnstate Hospital, Tergooi Hospital, UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

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