Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations With High Risk for EOS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06076200

Enrollment

Registered

2023-10-10

Start date

2023-09-30

Completion date

2026-12-31

Last updated

2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-Onset Neonatal Sepsis

Brief summary

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.

Interventions

DRUGPiperacillin Sodium and Tazobactam Sodium for Injection

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Clearance (L/h) of piperacillin/tazobactam	Through study completion, an average of 20 days.	The mean population pharmacokintic parameter as well as its interindividual variability
Volume of Distribution (L) of piperacillin/tazobactam	Through study completion, an average of 20 days.	The mean population pharmacokintic parameter as well as its interindividual variability

Secondary

Measure	Time frame	Description
PD target attainment	Through study completion, an average of 20 days.	PD target is defined as the time of free drug concentration beyond MIC during the dose interval
Adverse events	Through study completion, an average of 20 days.	Drug-related adverse events and serious adverse events during the study.

Countries

China

Contacts

Primary ContactWei Zhao, Ph.D

zhao4wei2@hotmail.com86053188383308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026