The aim of this study is to evaluate the efficacy of Eravacycline in the treatment of patients with bacterial infection and to assess the pharmacokinetics of Eravacycline and to establish a population pharmacokinetic model of Eravacycline.
Adult male or female aged 18-75 years
Not respond to initial empirical treatment, treatment time to reach Eravacycline steady-state concentration
Empirical antimicrobial treatment is ineffective
Eravacycline application for ≥ 3 days
Urinary tract infection
Allergic to Eravacycline, Tigecycline antibiotics or any excipients or have previously experienced serious adverse reactions
Any unstable or potentially endangering the safety of the subject and their compliance with the study as judged by the investigator; comorbidities or social circumstances that can make the subject unable to follow the study plan or even endanger the safety of the patient
Patients expected to survive for no longer than 48h.
100 critically infected patients
Cohort
Prospective
Not listed
Clinical remission rate
Completion of scheduled course of treatment; ≤14 days of treatment; treatment not restarted within 48 hours of discontinuation
Microbiological efficacy
Evaluate at the end of treatment and at post-treatment (discharge) in patients who met all clinical evaluation criteria and who had positive bacteriologic cultures prior to treatment, and bacterial clearance was calculated using the results of post-treatment follow-up (discharge) as the primary endpoint of evaluation.Performing safety observation (including coagulation dysfunction and other adverse reactions)
Develop Population Pharmacokinetic Model
Initial testing perform at first dose and steady-state testing perform at the seventh dose.Calculation of all-eravacycline fAUC using the linear trapezoidal method.Multiple regression analysis use to generate the best model equation for estimating the fAUC using the concentration of eravacycline at each sampling point in the modeling group as the independent variable and the fAUC as the dependent variable.
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