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

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.

Study Overview

• Status: Recruiting
• Conditions: Early-Onset Neonatal Sepsis
• Intervention / Treatment: Drug: Piperacillin Sodium and Tazobactam Sodium for Injection

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Wei Zhao, Ph.D; Phone Number: 86053188383308; Email: zhao4wei2@hotmail.com

Study Locations

• China
  • Jinan, China
    • Recruiting
    • Shandong Provincial Hospital
    • Contact: Yonghui Yu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The research population of this study is pregnant individuals whose baby at high risk of developing early-onset sepsis after birth.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Shandong Provincial Hospital
• Investigators: Principal Investigator: Wei Zhao, Ph.D, Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 23, 2023
• First Submitted That Met QC Criteria: October 7, 2023
• First Posted (Estimated): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Neonatal Sepsis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Piperacillin; Tazobactam
• Other Study ID Numbers: SDU-2023-PPK-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No