Unbound Cloxacillin Concentrations During Continuous Infusion

NCT ID: NCT06848387

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Staphylococcal Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Unbound cloxacillin concentration

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Unbound cloxacillin concentration

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Västmanland

OTHER

Sponsor Role collaborator

Emeli Månsson

OTHER

Sponsor Role lead

Responsible Party

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Emeli Månsson

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Emeli Månsson, PhD

Role: CONTACT

004621173000

Karl-Johan Lindner, PhD

Role: CONTACT

004621173000

Other Identifiers

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992496/KLONC

Identifier Type: -

Identifier Source: org_study_id

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