Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.

Summary

This study aims to compare the clinical outcomes, safety and PD target attainment of the model-based dose and empirical dose of piperacillin/tazobactam in the treatment of LOS in premature neonates, so as to optimize the piperacillin/tazobactam dose regimen.

Conditions

• Late-Onset Neonatal Sepsis

Interventions

DRUG

Piperacillin/tazobactam

Piperacillin Sodium and Tazobactam Sodium for Injection

Sponsors & Collaborators

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Qianfoshan Hospital

  collaborator OTHER

• Jinan Maternity and Child Care Hospital

  collaborator UNKNOWN

• Yantai Yuhuangding Hospital

  collaborator OTHER

• Hebei Petro China Center Hospital

  collaborator UNKNOWN

• Shengli Oilfield Hospital

  collaborator OTHER

• Liaocheng People's Hospital

  collaborator OTHER

• Jining Medical University

  collaborator OTHER

• W.F. Maternal and Child Health Hospital

  collaborator UNKNOWN

• Taian City Central Hospital

  collaborator OTHER

• Shandong University

  lead OTHER

Principal Investigators

• Wei Zhao, Ph.D · Shandong University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

72 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-31

Primary Completion

2024-12-31

Completion

2025-05-31

Countries

• China

Study Locations