Unbound Cloxacillin Concentrations During Continuous Infusion

Concentration of Unbound Cloxacillin in Adults Treated With Continuous Infusion Via Elastomeric Pump

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06848387

Acronym

KLONC

Enrollment

Registered

2025-02-27

Start date

2026-01-14

Completion date

2027-12-01

Last updated

2026-02-17

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

Conditions

Staphylococcal Infections

Keywords

cloxacillin

Brief summary

Cloxacillin is the first-line choice for the treatment of severe infections caused by the bacterium Staphylococcus aureus in Sweden. Over the past year, cloxacillin is increasingly administred through continuous infusion. In this study, the free (unbound) concentration of cloxacillin when administered as a continuous infusion will be measured to ensure that the free concentration is neither too high nor too low. A PK/PD model will be developed to predict which dosage of cloxacillin is appropriate for an individual based on age, gender, kidney function, and serum-protein level.

Interventions

DIAGNOSTIC_TESTUnbound cloxacillin concentration

Unbound cloxacillin concentration measured at baseline, after 4h, after 24h and after 48h of continuous infusion.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

Low intervention trial according to Regulation (EU) No 536/2014. The investigational medical product - cloxacillin - is authorized and according to the protocol of the clinical trial 1. Cloxacillin is used in accordance with the terms of the marketing authorization 2. The use of cloxacillin is evidence-based 3. The additional monitoring procedures - four blood samples drawn before, after 4h, after 24h, and after 48h of continuous infusion of cloxacillin - do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age 18 years or older * Treating physician has decided to start continuous infusion of cloxacillin

Exclusion criteria

* Unwilling or unable to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Free (unbound) cloxacillin concentration	From enrollment to end of follow up at 48 hours

Countries

Sweden

Contacts

CONTACTEmeli Månsson, PhD

emeli.mansson@regionvastmanland.se004621173000

CONTACTKarl-Johan Lindner, PhD

004621173000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026