RecruitingNCT06076200

Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

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


Sponsor

Shandong University

Enrollment

50 participants

Start Date

Sep 30, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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

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Interventions

DRUGPiperacillin 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(1)

Shandong Provincial Hospital

Jinan, China

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NCT06076200


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