Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

Launched by SHANDONG UNIVERSITY · Oct 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a combination antibiotic called piperacillin/tazobactam (often referred to as PIP/TAZO) in pregnant women who are at risk of having babies with early-onset sepsis, a serious infection that can occur shortly after birth. The researchers want to understand how this medication behaves in both the mothers and their newborns, ensuring it is safe and effective for preventing infections in these high-risk situations.

To participate in this study, women must be at least 18 years old, pregnant, and their babies should be at high risk of developing early-onset sepsis, requiring the use of PIP/TAZO. Participants will be informed about the study and will need to agree by signing a consent form. Throughout the trial, participants can expect close monitoring to ensure their safety and that of their babies. It’s important to note that individuals with serious allergies to antibiotics or those who have not taken PIP/TAZO within a certain time frame before delivery may not be eligible for this study.

Gender

FEMALE

Eligibility criteria

• 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