Status:
NOT_YET_RECRUITING
A Multicenter Clinical Study on the Continuous vs. Intermittent Infusion of Ceftazidime-Avibactam in Critically Ill Patients With Severe Infections
Lead Sponsor:
Southeast University, China
Conditions:
Patients With Critically Ill Infections
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
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 infusio...
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 ob...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT06939829
Start Date
May 1 2025
End Date
December 31 2027
Last Update
April 23 2025
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