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RECRUITING
NCT05655091
PHASE2

Target Attainment of Continuous Infusion Flucloxacillin and Cefazolin Coupled With TDM vs. Standard of Care Treatment in Patients With Complicated S. Aureus Infection

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

Summary

This prospective randomized, controlled interventional pilot trial, aims to compare the achievement of the optimal target concentration with continuously administered flucloxacillin (FLU) or cefazolin (CZO) coupled with TDM and subsequent dose adjustment versus standard of care (intermittent bolus application without TDM-guidance) in patients with complicated Staphylococcus aureus (S. aureus) infections (CSAI). The overall goal is to individualize and optimize antibiotic treatment in a very vulnerable group of patients overcoming the standard strategy of "one-dose-fits-all".

Official title: Can Continuous Infusion Coupled With Therapeutic Drug Monitoring Optimize Flucloxacillin and Cefazolin Target Attainment Compared to Standard Intermittent Bolus Dosing in Patients With Complicated Staphylococcus Aureus Infections? A Randomized, Controlled Interventional Pilot Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-10-26

Completion Date

2025-12

Last Updated

2024-12-16

Healthy Volunteers

No

Interventions

DRUG

FLU or CZO as continuous infusion

Continuous infusion FLU or CZO coupled with real-time TDM and subsequent dose adjustment. A loading dose will be administered prior to the first continuous infusion. The loading dose (maximum of 2g as licensed according to the SmPC) and the dose of the continuous infusion will be calculated according to a pharmacokinetic model taking into account patient's characteristics (e.g. age, sex) and the measured drug concentration. The maximum daily dose of FLU and CZO will not exceed 12 grams per day according to the SmPC.

DRUG

standard FLU or CZO intermittent bolus administration

Standard FLU or CZO intermittent bolus administration according to the local guidelines adjusted to the renal function without TDM-guided dose adjustment.

Locations (1)

University Hospital Basel, Division of Internal Medicine

Basel, Switzerland