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

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02993575
• Collaborator: Canisius-Wilhelmina Hospital (Other), Rijnstate Hospital (Other), UMC Utrecht (Other), Tergooi Hospital (Other), Gelderse Vallei Hospital (Other)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 10
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections	Drug: Flucloxacillin

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Pharmacokinetics of Flucloxacillin Given by Continuous or Intermittent Infusion as Therapy to Patients With an Infection in the Intensive Care Unit (ICU)
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Apr 1, 2018

Outcome Measures

Primary Outcome Measures

1. Clearance [Day 2 and 4]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radboud University Medical Center	Nijmegen		Netherlands

Sponsors and Collaborators

• Radboud University Medical Center
• Canisius-Wilhelmina Hospital
• Rijnstate Hospital
• UMC Utrecht
• Tergooi Hospital
• Gelderse Vallei Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radboud University Medical Center
• ClinicalTrials.gov Identifier: NCT02993575
• Other Study ID Numbers: UMCN-AKF-16.08
• First Posted: Dec 15, 2016
• Last Update Posted: Oct 23, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Radboud University Medical Center: Pharmacokinetics; Flucloxacillin; Continuous infusion; Intensive Care Unit
• Additional relevant MeSH terms: Infections; Bacterial Infections; Floxacillin

Study Results

No Results Posted as of Oct 23, 2018