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

Southeast University, China

Status and phase: Not yet enrolling; Phase 4

Conditions: Patients With Critically Ill Infections

Treatments: Drug: treatment with CAZ-AVI

Study type: Interventional

Funder types: Other

Identifiers

NCT06939829

2025ZDSYLL022

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

the intermittent infusion group

Active Comparator group

Description:

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.

Treatment:

Drug: treatment with CAZ-AVI

the continuous infusion group

Experimental group

Description:

After a loading dose of ceftazidime-avibactam, continuous infusion is administered, with the dose adjustment rules consistent with those of the intermittent infusion group.

Treatment:

Drug: treatment with CAZ-AVI