This study aims to compare the clinical outcomes, safety and PD target attainment of the model-based dose and empirical dose of piperacillin/tazobactam in the treatment of LOS in premature neonates, so as to optimize the piperacillin/tazobactam dose regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
332
Piperacillin Sodium and Tazobactam Sodium for Injection
Shengli Oilfield Hospital
Dongying, China
NOT_YET_RECRUITINGJinan Maternity and Child Care Hospital
Jinan, China
NOT_YET_RECRUITINGQianfoshan Hospital
Jinan, China
Successful outcome
Successful outcome is defined as: 1. Participant is alive. 2. No need for replacing the antibiotic or adding new antibiotics. 3. At the end of actual piperacillin/tazobactam therapy, ①there is a significant improvement in the participant's overall clinical status, ②there is microbiological resolution or presumed eradication of bacteria and ③no new piperacillin/tazobactam-susceptible pathogens potentially associated with sepsis have been identified. 4. Participant does not have a clinically or microbiologically significant relapse or new infection within 10 days after the end of actual piperacillin/tazobactam therapy.
Time frame: At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )
Length of NICU stay
Duration of hospital admission (days)
Time frame: From the date of randomization until date of discharge, assessed up to 2 months
All cause in-hospital mortality
Death before discharge from NICU
Time frame: From the date of randomization until date of discharge, assessed up to 2 months
Proportion of patients switching to or adding another antibiotics.
Proportion of patients switching to or adding another antibiotics by any reason.
Time frame: Through study completion, an average of 20 days.
Relapsed or new infection rate
Proportion of patients with clinically or microbiologically significant relapsed or new infection.
Time frame: At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )
PD target attainment
70%fT\>MIC
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Shandong Provincial Hospital
Jinan, China
NOT_YET_RECRUITINGJining Medical University
Jining, China
NOT_YET_RECRUITINGHebei Petro China Center Hospital
Langfang, China
NOT_YET_RECRUITINGLiaocheng People's Hospital
Liaocheng, China
NOT_YET_RECRUITINGTaian City Central Hospital
Tai’an, China
NOT_YET_RECRUITINGW.F. Maternal and Child Health Hospital
Weifang, China
NOT_YET_RECRUITINGYantai Yuhuangding Hospital
Yantai, China
RECRUITINGTime frame: Through study completion, an average of 20 days.
Adverse events
Drug-related adverse events and serious adverse events
Time frame: Through study completion, an average of 20 days.