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

Launched by SOUTHEAST UNIVERSITY, CHINA · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how the way a medication called ceftazidime-avibactam is given can affect critically ill patients with severe infections. Specifically, it aims to see if giving the medication continuously (without breaks) is more effective than giving it in intervals. This study is focused on patients who are admitted to intensive care units (ICUs) and are dealing with infections caused by tough-to-treat bacteria.

To participate in the trial, patients need to be between 18 and 85 years old and have been diagnosed with a specific type of infection that has shown resistance to other treatments. They must also be experiencing serious health issues, such as low blood pressure or requiring help to breathe. However, not everyone can join; for example, those who are allergic to the medication or are in extremely critical condition will not be eligible. Participants can expect to receive close monitoring and care as part of the study, which aims to find the best way to use this important antibiotic in very ill patients.

Gender

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Eligibility criteria

• 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.