Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Piperacillin Sodium and Tazobactam Sodium for Injection.
- Who it may be relevant to
- Registry conditions: Early-Onset Neonatal Sepsis. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations With High Risk for EOS
Overview
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.
Interventions
- 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.
Primary outcome measures
- Clearance (L/h) of piperacillin/tazobactam [Time frame: Through study completion, an average of 20 days.]
- Volume of Distribution (L) of piperacillin/tazobactam [Time frame: Through study completion, an average of 20 days.]
Secondary outcome measures (2)
- PD target attainment [Time frame: Through study completion, an average of 20 days.]
- Adverse events [Time frame: Through study completion, an average of 20 days.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shandong Provincial Hospital — Jinan
Identifiers
NCT: NCT06076200 · SDU-2023-PPK-005