Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

• Sponsor: Shandong University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06076200
• Collaborator: Shandong Provincial Hospital (Other)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Early-Onset Neonatal Sepsis	Drug: Piperacillin Sodium and Tazobactam Sodium for Injection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations With High Risk for EOS
• Anticipated Study Start Date: Sep 30, 2023
• Anticipated Primary Completion Date: Jul 1, 2026
• Anticipated Study Completion Date: Dec 31, 2026

Outcome Measures

Primary Outcome Measures

1. Clearance (L/h) of piperacillin/tazobactam [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 [Through study completion, an average of 20 days.]

   The mean population pharmacokintic parameter as well as its interindividual variability

Secondary Outcome Measures

1. PD target attainment [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 [Through study completion, an average of 20 days.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shandong Provincial Hospital	Jinan		China

Sponsors and Collaborators

• Shandong University
• Shandong Provincial Hospital

Investigators

• Principal Investigator: Wei Zhao, Ph.D, Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wei Zhao, Head of department of clinical pharmacy and pharmacology, Shandong University
• ClinicalTrials.gov Identifier: NCT06076200
• Other Study ID Numbers: SDU-2023-PPK-005
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Neonatal Sepsis; Tazobactam; Piperacillin

Study Results

No Results Posted as of Oct 10, 2023