CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime/AVIbactam in Critically Ill Patients

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

May 1, 2027

Study Completion Date

August 1, 2027

Conditions
Severe Infection
Interventions
DRUG

Continuos ceftazidime/avibactam infusion

Continuous infusion will include a loading dose of 2 g/0.5 g administered over 2 hours, followed by continuous infusion of 6 g/1.5 g over 24 hours, equivalent to 0.25 g of ceftazidime per hour. The drug reconstitution and dilution process are shown in Figure 2. The final volume of solution of CZA will be 50 mL, which gives concentration of ceftazidime of 40 mg/mL, with 4:1 concentration ratio for avibactam (10 mg/mL). The solution will be administered via an infusion syringe, with an infusion rate of 6.25 mL/h. Dose adjustments will be applied according to renal function, calculated using Cockroft-Gault formula

DRUG

Intermitent dosing as per SMPC

Intermittent dosing, as outlined in the SmPC, consists of 2 g/0.5 g administered by prolonged infusion over 2 hours every 8 hours. Dose adjustments will be applied according to renal function, calculated using Cockroft-Gault formula.

All Listed Sponsors
collaborator

UHC Zagreb, Zagreb, Croatia

OTHER_GOV

collaborator

Daniel Lovrić

UNKNOWN

collaborator

Mirna Momčilović

UNKNOWN

lead

Ivan Šitum, MD

OTHER