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NCT Number: NCT06939829

A Multicenter Clinical Study on the 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 90-day all cause mortality

    Time frame: from randomization to day 90

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lin lin Hu, PhD

CONTACT

[email protected]

+86-025-83272127

feng jian Xie, MD

CONTACT

[email protected]

+86-025-83262552

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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

Acronym: AVIATOR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.