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).
18-85 years old.
Hospitalized participants in ICU who did not receive Ceftazidime Avibactam treatment within 15 days before joining the study.
Participants with severe infection (refer to the 2022 sepsis3.0 guidelines for the definition of severe infection).
at least one carbapenem-resistant Gram-negative pathogen (including but not limited to carbapenem-resistant Enterobacteriaceae and / or Pseudomonas aeruginosa) was confirmed by bacterial culture in the primary infection site samples.
Participants are less than 18.
Death within 72 hours after the start of treatment.
Known resistance to β-lactam antibacterial drugs including cephalosporins, cephalosporin compound preparations containing β-lactamase inhibitors, or Those with a history of allergies to ceftazidime avibactam sodium for injection and its excipients.
No indication for treatment with ceftazidime avibactam.
critically ill patients in ICU with CRO infections (including dialysis patients and ECMO patients).
Cohort
Prospective
ceftazidime avibactam
DrugRoutine 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
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.
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
