RecruitingNot Applicable

Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

China50 participantsStarted 2023-09-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Clearance (L/h) of piperacillin/tazobactam

Timeframe: Through study completion, an average of 20 days.

Volume of Distribution (L) of piperacillin/tazobactam

Timeframe: Through study completion, an average of 20 days.

Trial details

NCT IDNCT06076200

SponsorShandong University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07-01

Contact for this trial

Wei Zhao, Ph.D

86053188383308 zhao4wei2@hotmail.com

View on ClinicalTrials.gov More Early-Onset Neonatal Sepsis trials