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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSoutheast University, China

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • treatment with CAZ-AVI

    Drug

    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.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: the intermittent infusion groupActive comparator 1 intervention
Group B: the continuous infusion groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

90-day all cause mortality

the proportion of subjects who die within 90 days after randomization to the number of subjects in each group

Time frame
from randomization to day 90

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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