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Ceftazidime/avibactam (CAZ/AVI) is a new β-lactam drug, which has good antibacterial effect against carbapenem resistant enterobacter. However, previous studies found that CAZ/AVI had a low PK/PD compliance rate after the recommended dose of the drug instructions.Therefore, this study was intended to explore the clinical efficacy of different administration schedules of CAZ/AVI for patients with severe infection, and further analyze the correlation between CAZ/AVI PK/PD parameters and clinical efficacy and adverse reactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Ceftazidime/avibactam(Taidingping®, Qilu Pharmaceutical Co., Ltd.) loading dose of 2.5g (2h infusion), then the standard dose and administration schedule, namely 2.5gQ8h, continuous infusion, the dose can be adjusted according to the instructions of renal function,The duration of medication is determined by the clinician |
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| control group | Experimental | Ceftazidime/avibactam(Taidingping®, Qilu Pharmaceutical Co., Ltd.)were given a load dose of 2.5g (2h infusion), followed by 2.5gQ8h, the dose can be adjusted according to renal function.The duration of medication is determined by the clinician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAZ/AVI | Drug | continuous infusion is used |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical effective rate | According to the Technical Guidelines for Clinical Trials of Antimicrobial Drugs, clinical efficacy is defined as: (1) effective: symptoms, signs, pathogenic microbiology and various tests and examination indicators are significantly improved;(2) Ineffective: the patient's condition has not improved or worsened, and other antibacterial drugs need to be replaced.Effective rate = Number of effective cases/total cases x 100%. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial removal | Defined as clearance or change of existing bacteria within two weeks of medication. | 14 days |
| 28-d mortality | Defined as whether a patient died at 28-d after follow-up.28-d Mortality rate = Number of deaths/group size x 100%. |
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Inclusion Criteria:
Multiple-resistant negative bacteria Sensitive to ceftazidime/avibactam Received intravenous infusion of ceftazidime/avibactam
Exclusion Criteria:
Allergic to ceftazidime/avibactam Blood sample not be collected Pregnant or lactating
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Xu, Ph.D | Contact | 0086+(025)83106666 | ctboycm@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Xu, Ph.D | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Care Unit, Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210009 | China |
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Treatment group and control group
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A non-blind study
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| CAZ/AVI | Drug | 2h-infusion is used |
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| 28 days |
| PK/PD compliance rate | PK/PD compliance rate = number of qualified persons/number of groups × 100%. | 14 days |