Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

Recruiting

• Conditions: Early-Onset Neonatal Sepsis

• Registration Number: NCT06076200
• Lead Sponsor: Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-23
• Study Start: 2023-09-30
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-07
• Last Update Submitted: 2023-10-07
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Shandong Provincial Hospital; 🇨🇳 Jinan, China