A Multicenter Clinical Study on the Continuous vs. Intermittent Infusion of Ceftazidime-Avibactam in Critically Ill Patients With Severe Infections (AVIATOR)

A Prospective, Open-Label, Randomized Controlled, Multicenter Clinical Study on Continuous vs. Intermittent Infusion of Ceftazidime-Avibactam in Critically Ill Patients With Severe Infections

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients With Critically Ill Infections
• Intervention / Treatment: Drug: treatment with CAZ-AVI

Detailed Description

This study employs a prospective, open-label, randomized controlled, multicenter clinical trial design comparing "CAZ-AVI continuous infusion" versus "CAZ-AVI intermittent infusion," .The secondary objectives is to observe the clinical cure, Bacterial clearance, the probability of target attainment (PTA) of TDM. etc

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: feng jian Xie, MD; Phone Number: +86-025-83262552; Email: xie820405@126.com
• Study Contact Backup: Name: Lin lin Hu, PhD; Phone Number: +86-025-83272127; Email: eliza50@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

iv. Serum creatinine concentration > 220 μmol/L or >2.49 mg/dL

Exclusion Criteria:

• 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.
• Patient is known or suspected to be pregnant.
• Patient has previously been enrolled in the current study.
• Other conditions which are regarded as inappropriate for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the intermittent infusion group; Ceftazidime-avibactam will be administered as 2.5 g q8h by intermittent infusion for 2 h, and the dosage could be adjusted according to the instructions.	Drug: treatment with CAZ-AVI; Randomize 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.
Experimental: the continuous infusion group; After a loading dose of ceftazidime-avibactam, continuous infusion is administered, with the dose adjustment rules consistent with those of the intermittent infusion group.	Drug: treatment with CAZ-AVI; Randomize 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-day all cause mortality	the proportion of subjects who die within 90 days after randomization to the number of subjects in each group	from randomization to day 90

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Study Chair: Feng jian Xie, MD, Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: clinical study; Ceftazidime-Avibactam; Continuous versus Intermittent Infusion
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Infections; Communicable Diseases
• Other Study ID Numbers: 2025ZDSYLL022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No