Flucloxacillin absorption test validation and optimalisation.

Prediction of Flucloxacillin Absorption and %time/MIC using the Flucloxacillin absorption test - PFAF

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003933-40-NL

Enrollment

Registered

2020-01-14

Start date

2020-06-24

Completion date

Unknown

Last updated

2021-06-14

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

Conditions

S Aureus bacteraemia (indirectly)

Interventions

Trade Name: FLUCLOXACILLINE CAPSULE 500MG Mylan RVG10928 FLUCLOXACILLINE CAPSULE 500MG Apotex RVG 18564 FLUCLOXACILLINE CAPSULE 500MG Aurobindo RVG 16940 FLUCLOXACILLINE CAPSULE 500MG Sandoz RVG 32165

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: >18 years Admitted to the hospital S aureus infection with continuous infusion of flucloxacillin Clinically eligible to be switched to oral flucloxacillin Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: ICU admittance Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Our aim is to evaluate whether the current flucloxacillin absorption test is able to adequately predict the absorption of flucloxacillin compared to an absorption test after switch.;Secondary Objective: Our secondary objective is to identify co-variants in order to improve the predictability, optimize and/or simplify the test.;Primary end point(s): The prediction of time above MIC of both the 3 point concentration curves and 7 point concentration curves per patient before and after switch to oral flucloxacillin will be compared. > 50% time above MIC is considered sufficient;Timepoint(s) of evaluation of this end point: not applicable	—

Measure

Time frame

Main Objective: Our aim is to evaluate whether the current flucloxacillin absorption test is able to adequately predict the absorption of flucloxacillin compared to an absorption test after switch.;Secondary Objective: Our secondary objective is to identify co-variants in order to improve the predictability, optimize and/or simplify the test.;Primary end point(s): The prediction of time above MIC of both the 3 point concentration curves and 7 point concentration curves per patient before and after switch to oral flucloxacillin will be compared. > 50% time above MIC is considered sufficient;Timepoint(s) of evaluation of this end point: not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Population pharmacokinetic analysis will be performed by use of NONMEM to develop an integrated model for total and free concentration en covarianten;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Netherlands

Contacts

Public ContactEveline Roelofsen

Haaglanden Medisch Centrum

e.roelofsen@haaglandenmc.nl+31889793175

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026