Patients With Critically Ill Infections
Conditions
Keywords
Ceftazidime-Avibactam, Continuous versus Intermittent Infusion, clinical study
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 infusion.
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 objectives is to observe the clinical cure, Bacterial clearance, the probability of target attainment (PTA) of TDM. etc
Interventions
DRUGtreatment with CAZ-AVI
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.
Sponsors
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day all cause mortality | from randomization to day 90 | the proportion of subjects who die within 90 days after randomization to the number of subjects in each group |
Contacts
Primary Contactfeng jian Xie, MD
Backup ContactLin lin Hu, PhD
Outcome results
None listed