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Clinical Trials in China / NCT06076200
Recruiting Observational

Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

NCT06076200 · tracked via the Priya Life Science China tracker
Sponsor
Shandong University
Phase
Observational
Started
2023-09-30
Last updated
2023-10-10

Condition(s) studied

Early-Onset Neonatal Sepsis

Investigational drug(s) / intervention(s)

Piperacillin Sodium and Tazobactam Sodium for Injection

Piperacillin 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 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shandong Provincial Hospital Jinan China Recruiting

More Shandong University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06076200 on ClinicalTrials.gov ↗ ← All trials in China