Unbound Cloxacillin Concentrations During Continuous Infusion

NCT06848387 | Recruiting Phase 4

• 1 other identifier: 992496/KLONC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcal Infections

Keywords

cloxacillin

Outcome Measures

Primary Outcomes (1)

• Free (unbound) cloxacillin concentration

  From enrollment to end of follow up at 48 hours

Study Arms (1)

Treatment with cloxacillin as continuous infusion via elastomeric pump

EXPERIMENTAL

Additional monitoring procedures performed: blood samples drawn before, after 4h, after 24h, and after 48h of continuous infusion of cloxacillin.

Diagnostic Test: Unbound cloxacillin concentration

Interventions

Unbound cloxacillin concentration DIAGNOSTIC_TEST

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

Treatment with cloxacillin as continuous infusion via elastomeric pump

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unwilling or unable to provide written informed consent

Sponsors & Collaborators

• Emeli Månsson: lead
• Region Västmanland: collaborator

Study Sites (1)

Västmanlands sjukhus Västerås

Västerås, Sweden

RECRUITING

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Emeli Månsson, PhD

CONTACT

004621173000; emeli.mansson@regionvastmanland.se

Karl-Johan Lindner, PhD

CONTACT

004621173000

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: February 27, 2025
• Study Start: January 14, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)