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

Shandong University

Status and phase: Enrolling; Phase 4

Conditions: Late-Onset Neonatal Sepsis

Treatments: Drug: Piperacillin/tazobactam

Study type: Interventional

Funder types: Other

Identifiers

NCT05981079

SDU-2023-NeoPIP-002

Details and patient eligibility

About

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.

Enrollment: 332 estimated patients

Sex: All

Ages: 72+ hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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332 participants in 2 patient groups

Model-based dosing regimen

Experimental group

Description:

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.

Treatment:

Drug: Piperacillin/tazobactam

Empirical dosing regimen

Active Comparator group

Description:

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

Treatment:

Drug: Piperacillin/tazobactam