Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorShandong University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Piperacillin Sodium and Tazobactam Sodium for Injection

    Drug

    Piperacillin/Tazobactam, specification: 4g; 0.5g. Anti-infective therapy with piperacillin/tazobactam, specific regimen based on clinical practice, without intervention.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Clearance (L/h) of piperacillin/tazobactam

The mean population pharmacokintic parameter as well as its interindividual variability

Time frame
Through study completion, an average of 20 days.
2

Volume of Distribution (L) of piperacillin/tazobactam

The mean population pharmacokintic parameter as well as its interindividual variability

Time frame
Through study completion, an average of 20 days.

Secondary outcomes

1

PD target attainment

PD target is defined as the time of free drug concentration beyond MIC during the dose interval

Time frame
Through study completion, an average of 20 days.
2

Adverse events

Drug-related adverse events and serious adverse events during the study.

Time frame
Through study completion, an average of 20 days.

Other outcomes

Sponsors and contacts

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Shandong University

Lead sponsor

Shandong Provincial Hospital

Collaborator