NCT02993575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

December 12, 2016

Last Update Submit

October 22, 2018

Conditions

Bacterial Infections

Keywords

PharmacokineticsFlucloxacillinContinuous infusionIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Clearance

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

    Day 2 and 4

Interventions

FlucloxacillinDRUG

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

Also known as: Floxapen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients receiving flucloxacillin for treating a suspected or proven bacterial infection at the ICU will be included.

You may qualify if:

  • 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

You may not qualify if:

  • \. Has previously participated in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples for determination of total flucloxacillin and free flucloxacillin

MeSH Terms

Conditions

Bacterial Infections

Interventions

Floxacillin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

CloxacillinOxacillinPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 15, 2016

Study Start

June 1, 2017

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)