drugset / Trial / NCT05981079
Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.
Phase 4
Unknown
332 enrolled
Shandong University
Hebei Petro China Center Hospital · collabJinan Maternity and Child Care Hospital · collabJining Medical University · collabLiaocheng People's Hospital · collabQianfoshan Hospital · collabShandong Provincial Hospital · collabShengli Oilfield Hospital · collabTaian City Central Hospital · collabW.F. Maternal and Child Health Hospital · collabYantai Yuhuangding Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-07-31
- Primary completion
- 2024-12-31
- Completion
- 2025-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Piperacillin | Small molecule | — | — |
| Subject | Tazobactam | Small molecule | — | — |