Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

Recruiting now

Conditions studied: Early-Onset Neonatal Sepsis

In brief

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.

Key facts

Study ID

NCT06076200

Run by

Shandong University

People needed

50

Starts

2023-09-30

Expected to finish

2026-12-31

Last updated by the study team

2023-10-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Shandong Provincial Hospital — Jinan, China (enrolling)

Full record on ClinicalTrials.gov

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