Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Early-Onset Neonatal Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No