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The goal of this study is to evaluate the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients).
This is a prospective observational multicentre study. The study is to obtain the real world data of the efficacy and safety of ceftazidime-avibactam(CAZ-AVI) in the treatment of critically ill patients with carbapenem-resistant organisms(CRO) infections (including dialysis patients and extracorporeal membrane oxygenation(ECMO) patients) by using therapeutic drug monitoring(TDM). A population-pharmacokinetic(PPK) model of CAZ-AV in these patients will be established in this study. The main question it aims to answer is the clinical success rate and microbiological success rate of CAZ-AVI based regimen in the treatment of critically ill patients with CRO infections. According to the clinical practice (symptoms, signs, imaging, culture and drug sensitivity, etc.), the doctor determines the combined regimen of CAZ-AVI, and the combined drugs are used routinely according to their instructions or clinical diagnosis and treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ceftazidime avibactam | Drug | Routine treatment dose for patients: the recommended intravenous dose for patients with creatinine clearance rate (eCrCL) > 50ml/min was 2.5g (2g/0.5g), once every 8 hours, and the infusion time was 2 hours. Patients with renal injury adjust the dosage according to eCrCL |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success rate at the end of treatment and/or the time transfer out of ICU | Clinical success includes cure or symptom improvement, which means that all symptoms and signs of patients have completely recovered or significantly improved before the end of treatment and/or the time transfer out of ICU, or imaging and other non-microbiological indicators have returned to normal. The proportion of patients with cured or improved symptoms in the total population was analyzed. | the end of treatment or the time transfer out of ICU,up to 1 year. |
| Microbiologic success rate at the end of treatment and/or the time transfer out of ICU | Microbiological clearance includes clearance or presumed clearance. Clearance means that the pathogenic bacteria of the original infection have not been cultured from specimens from the original infected site after treatment; presumed clearance means that in some diseases, the disappearance of symptoms and signs makes it impossible to obtain culturable materials (such as sputum, skin pus or secretions). ), or the method of obtaining the specimen is too invasive for the recovered patient, the microbiological results are considered presumptive clearance. The microbial clearance rate is the proportion of patients who are cleared or presumed to be cleared to the total analyzed population. | the end of treatment or the time transfer out of ICU,up to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality on day 28 after drug initiation | All-cause mortality refers to the proportion of the total number of deaths caused by various causes within a certain period to the total analyzed population. It is necessary to count the number of deaths caused by various causes during this period as of the 28th day after the start of medication, using the Clopper-Pearson method. Calculate the 95% confidence interval for all-cause mortality on day 28 after drug initiation. |
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Inclusion Criteria:
Exclusion Criteria:
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critically ill patients in ICU with CRO infections (including dialysis patients and ECMO patients).
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| ID | Term |
|---|---|
| C000595613 | avibactam, ceftazidime drug combination |
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Blood samples
| 28 days from drug initiation |
| Infection-related mortality during hospitalization in ICU | The proportion of patients who died due to infection to the total analyzed population was calculated using the Clopper-Pearson method to calculate the 95% confidence interval for infection-related mortality. It should be noted that in-hospital deaths that occur after infection symptoms improve are not considered to be related to the infection. | the end of treatment or the time transfer out of ICU,up to 1 year. |
| All-cause mortality on 90 days after drug initiation | As of the 90th day after the start of medication, the number of deaths due to various causes during this time period accounted for the proportion of the total population analyzed. | 90 days from drug initiation |
| Recurrence rate of infection on day 28 after starting medication | As of the 28th day after the start of medication, the number of people whose infection was controlled and then relapsed during this time period accounted for the proportion of the total analyzed population. | 28 days from drug initiation |
| Length of ICU Stay | Length of stay in ICU = date of discharge from ICU - date of admission to ICU + 1. | the end of treatment or the time transfer out of ICU,up to 1 year. |
| Length of Hospital Stay (LOS) | Length of stay = discharge date - admission date + 1. | the end of treatment or the time transfer out of ICU,up to 1 year. |
| Time from ceftazidime-avibactam treatment initiation to symptom improvement | As an indicator of time event type, the clinical outcome of the patients was marked as the end event of symptom improvement, and the patients who did not achieve symptom improvement at the observation deadline were marked as deletion. The median value and 95% confidence interval were estimated by Kaplan-Meier method. | the end of treatment or the time transfer out of ICU,up to 1 year. |