Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

Early-Onset Neonatal Sepsis Clinical Trial

Official title:

Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations With High Risk for EOS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06076200
• Other study ID #: SDU-2023-PPK-005
• Status: Recruiting
• Start date: September 30, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Shandong University
• Contact: Wei Zhao, Ph.D
• Phone: 86053188383308
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Early-Onset Neonatal Sepsis
• Neonatal Sepsis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan

Sponsors (2)

Lead Sponsor	Collaborator
Shandong University	Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	Adverse events	Drug-related adverse events and serious adverse events during the study.	Through study completion, an average of 20 days.