NCT05981079

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

Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in the Treatment of Late-onset Sepsis in Preterm Neonates: a Multicentre, Randomised, Open-label, Non-inferiority Study.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 332 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Piperacillin/tazobactam	Piperacillin Sodium and Tazobactam Sodium for Injection

Timeline

• Start date: 2023-07-31
• Primary completion: 2024-12-31
• Completion: 2025-05-31
• First posted: 2023-08-08
• Last updated: 2023-08-08

Locations

10 sites across 1 country: China