Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

NCT06076200 | Recruiting

• 1 other identifier: SDU-2023-PPK-005
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early-Onset Neonatal Sepsis

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• PD target attainment

  Through study completion, an average of 20 days.

• Adverse events

  Through study completion, an average of 20 days.

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The research population of this study is pregnant individuals whose baby at high risk of developing early-onset sepsis after birth.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shandong University: lead
• Shandong Provincial Hospital: collaborator

Study Sites (1)

Shandong Provincial Hospital

Jinan, China

RECRUITING

Biospecimen

Biological samples include blood samples, amniotic fluid samples, placenta samples, maternal milk samples in pregnant women and umbilical cord blood samples.

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Piperacillin; Tazobactam; Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillanic Acid; Sulfones; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Wei Zhao, Ph.D

  Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Zhao, Ph.D

CONTACT

86053188383308; zhao4wei2@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of clinical pharmacy and pharmacology

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: October 10, 2023
• Study Start: September 30, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

CN (1)