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.
Study Type
OBSERVATIONAL
Enrollment
100
Clinical remission rate
Completion of scheduled course of treatment; ≤14 days of treatment; treatment not restarted within 48 hours of discontinuation
Time frame: At the end of treatment；2 weeks（estimated）
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)
Time frame: From enrollment to the end of treatment at 28 days
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.
Time frame: From enrollment to the end of treatment at 28 days
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