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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the intermittent infusion group | Active Comparator | Ceftazidime-avibactam will be administered as 2.5 g q8h by intermittent infusion for 2 h, and the dosage could be adjusted according to the instructions. |
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| the continuous infusion group | Experimental | After a loading dose of ceftazidime-avibactam, continuous infusion is administered, with the dose adjustment rules consistent with those of the intermittent infusion group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 90-day all cause mortality | the proportion of subjects who die within 90 days after randomization to the number of subjects in each group | from randomization to day 90 |
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Inclusion Criteria:
iv. Serum creatinine concentration > 220 μmol/L or >2.49 mg/dL
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| feng jian Xie, MD | Contact | +86-025-83262552 | xie820405@126.com | |
| Lin lin Hu, PhD | Contact | +86-025-83272127 | eliza50@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng jian Xie, MD | Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University | Study Chair |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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