Unbound Cloxacillin Concentrations During Continuous Infusion (KLONC)

February 12, 2026 updated by: Emeli Månsson

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Karl-Johan Lindner, PhD
  • Phone Number: 004621173000

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Adult hospitalized patients treated with cloxacillin continouos infusion

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with cloxacillin as continuous infusion via elastomeric pump
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
Unbound cloxacillin concentration measured at baseline, after 4h, after 24h and after 48h of continuous infusion.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emeli Månsson

Collaborators

Region Västmanland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

February 23, 2025

First Posted (Actual)

February 27, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 992496/KLONC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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