Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

Shandong University

Status: Enrolling

Conditions: Early-Onset Neonatal Sepsis

Treatments: Drug: Piperacillin Sodium and Tazobactam Sodium for Injection

Study type: Observational

Funder types: Other

Identifiers

NCT06076200

SDU-2023-PPK-005

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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