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NCT Number: NCT06076200

Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

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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Key information

Conditions

Early-Onset Neonatal Sepsis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Shandong Provincial Hospital

Jinan, China

Location status: Recruiting

Location contact

Yonghui Yu

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Piperacillin Sodium and Tazobactam Sodium for Injection

Drug

Piperacillin/Tazobactam, specification: 4g; 0.5g. Anti-infective therapy with piperacillin/tazobactam, specific regimen based on clinical practice, without intervention.

Primary outcomes

  1. Clearance (L/h) of piperacillin/tazobactam

    Time frame: Through study completion, an average of 20 days.

    The mean population pharmacokintic parameter as well as its interindividual variability

  2. Volume of Distribution (L) of piperacillin/tazobactam

    Time frame: Through study completion, an average of 20 days.

    The mean population pharmacokintic parameter as well as its interindividual variability

Secondary outcomes

  1. PD target attainment

    Time frame: Through study completion, an average of 20 days.

    PD target is defined as the time of free drug concentration beyond MIC during the dose interval

  2. Adverse events

    Time frame: Through study completion, an average of 20 days.

    Drug-related adverse events and serious adverse events during the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Zhao, Ph.D

CONTACT

[email protected]

86053188383308

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Collaborators

  • Shandong Provincial Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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