About this trial
The purpose of this study is to describe the population pharmacokinetic characteristics of piperacillin/tazobactam after intravenous administration in pregnant women during pregnancy and delivery, and to evaluate pharmacodynamic effectiveness and safety of piperacillin/tazobactam in pregnant women whose baby are at high risk of developing early-onset sepsis after birth.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years old;
Pregnant women whose baby are at high risk of developing early-onset sepsis after birth have indications to use preventive or therapeutic antibiotics, and the antibiotics used are PIP/TAZO;
Patients and their families are fully aware of the research content and sign the informed consent form.
Disqualifiers
Intolerance or serious adverse reactions to antibiotic use;
Patients who stopped using PIP/TAZO more than 24 hours before delivery;
Receiving other systemic trial drugs;
There are other factors that the researchers think are not suitable for inclusion
Trial population
The research population of this study is pregnant individuals whose baby at high risk of developing early-onset sepsis after birth.
Trial design
Cohort
Prospective
Treatments tested in this trial
Piperacillin Sodium and Tazobactam Sodium for Injection
DrugPiperacillin/Tazobactam, specification: 4g; 0.5g. Anti-infective therapy with piperacillin/tazobactam, specific regimen based on clinical practice, without intervention.
Treatment groups
Trial outcomes
Primary outcomes
Clearance (L/h) of piperacillin/tazobactam
The mean population pharmacokintic parameter as well as its interindividual variability
Volume of Distribution (L) of piperacillin/tazobactam
The mean population pharmacokintic parameter as well as its interindividual variability
Secondary outcomes
PD target attainment
PD target is defined as the time of free drug concentration beyond MIC during the dose interval
Adverse events
Drug-related adverse events and serious adverse events during the study.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shandong University
Lead sponsor
Shandong Provincial Hospital
Collaborator