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

PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 26, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Complicated Staphylococcus Aureus (S. Aureus) Infections (CSAI)
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.

Trial Locations (1)

4031

RECRUITING

University Hospital Basel, Division of Internal Medicine, Basel

All Listed Sponsors
lead

University Hospital, Basel, Switzerland

OTHER