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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Late-Onset Neonatal Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Model-based dosing regimen

Drug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: GA\<28 weeks: 30 mg/kg, Q8H; 28 weeks ≤GA\<34 weeks: 50 mg/kg，Q8H.

Group Type EXPERIMENTAL

Piperacillin/tazobactam

Intervention Type DRUG

Piperacillin Sodium and Tazobactam Sodium for Injection

Empirical dosing regimen

Drug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: 90 mg/kg，Q8H.

Group Type ACTIVE_COMPARATOR

Piperacillin/tazobactam

Intervention Type DRUG

Piperacillin Sodium and Tazobactam Sodium for Injection

Interventions

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Piperacillin/tazobactam

Piperacillin Sodium and Tazobactam Sodium for Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Preterm neonates: gestational age \<34 weeks;
* Postnatal age \> 72h;
* Postmenstrual age \<36 weeks;
* Newly diagnosed as late-onset sepsis;
* Parental written consent.

Exclusion Criteria

* Patient with bacterial meningitis, osteomyelitis, septic arthritis or necrotizing enterocolitis requiring surgery.
* High suspicion of/confirmed fungal infection.
* Severe congenital malformations and/or severe organ failure.
* Administration of any systemic antibiotic regimen 24 h before screening.
* Administration of other systemic trial drug therapy.
* Other factors that the researcher considers unsuitable for inclusion.
* Post-randomization Exclusion: ①Patients with a positive baseline blood culture and the pathogen resistant to PIP/TAZO. ②Patients with bacterial meningitis, fungal infection, osteomyelitis, septic arthritis or necrotizing enterocolitis requiring surgery after randomization.

Minimum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Wei Zhao

Head of department of clinical pharmacy and pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Zhao, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shandong University

Locations

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