About this trial
The objective of this study is to determine whether continuous infusion of ceftazidime-avibactam (CAZ-AVI) could improve clinical outcomes in critically ill patients compared with intermittent infusion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-85 years old, male or female.
Patients who are admitted to ICU wards.
Patients clinically diagnosed with carbapenem-resistant organism (CRO) infections, and has been commenced on targeted therapy with ceftazidime-avibactam.
One or more organ dysfunction criteria in the previous 24 hours i. MAP < 60 mmHg for at least 1 hour; ii. Vasopressors required for > 4 hours; iii. Respiratory support using supplemental high flow nasal prongs, continuous positive airway pressure, bilevel positive airway pressure or invasive mechanical ventilation for at least 1 hour.
Disqualifiers
Patient has a known allergy to ceftazidime-avibactam.
Patient has received ceftazidime-avibactam for more than 48 hours during current infectious episode.
Patient is in severe condition or expected to survive for no more than 48 hours.
Patient who receives lung or heart transplant or stem cell transplant.
Trial design
Parallel
Treatments tested in this trial
treatment with CAZ-AVI
DrugRandomize subjects to receive CAZ-AVI via either continuous infusion or intermittent infusion. The total daily dose and dosing interval should be determined according to the subject's body weight, renal function, and estimated drug clearance based on standard prescribing guidelines. Regardless of administration method, the same criteria for dose adjustment (including indications for modification and monitoring parameters) must be consistently applied to both control and experimental groups.
Treatment groups
Trial outcomes
Primary outcomes
90-day all cause mortality
the proportion of subjects who die within 90 days after randomization to the number of subjects in each group
Locations
Sponsors and contacts
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