Unbound Cloxacillin Concentrations During Continuous Infusion (KLONC)

Emeli Månsson

Status and phase: Begins enrollment in 4 months; Phase 4

Conditions: Staphylococcal Infections

Treatments: Diagnostic Test: Unbound cloxacillin concentration

Study type: Interventional

Funder types: Other

Identifiers

NCT06848387

992496/KLONC

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

Treatment with cloxacillin as continuous infusion via elastomeric pump

Experimental group

Description:

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

Treatment:

Diagnostic Test: Unbound cloxacillin concentration