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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06076200
Other study ID # SDU-2023-PPK-005
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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