Comparing model-based and empirical dosing of piperacillin/tazobactam for 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.

This study is testing whether a new way of giving the antibiotic piperacillin/tazobactam can help preterm babies with late-onset sepsis get better results than the usual method.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 332 (estimated)
• Ages: 72 Hours and up
• Sex: All
• Sponsor: Shandong University (Academic / other)
• Locations: 10 sites (Dongying and 9 other locations)
• Trial ID: NCT05981079 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the clinical outcomes and safety of model-based dosing versus empirical dosing of piperacillin/tazobactam in treating late-onset sepsis in preterm neonates. By optimizing the dosing regimen, the study seeks to improve pharmacodynamic target attainment and overall treatment efficacy. Preterm neonates with specific eligibility criteria will be enrolled, and their responses to the different dosing strategies will be monitored. The goal is to determine which dosing method provides better outcomes for this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates for this study are preterm neonates born at less than 34 weeks gestational age who are newly diagnosed with late-onset sepsis.

Not a fit: Patients with bacterial meningitis, fungal infections, or severe congenital malformations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and safer dosing strategies for treating late-onset sepsis in preterm neonates.

How similar studies have performed: Other studies have shown promise in optimizing antibiotic dosing in neonates, but this specific approach is relatively novel.

Eligibility criteria

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.

Where this trial is running

Dongying and 9 other locations

• Shengli Oilfield Hospital — Dongying, China (Not_yet_recruiting)
• Jinan Maternity and Child Care Hospital — Jinan, China (Not_yet_recruiting)
• Qianfoshan Hospital — Jinan, China (Not_yet_recruiting)
• Shandong Provincial Hospital — Jinan, China (Not_yet_recruiting)
• Jining Medical University — Jining, China (Not_yet_recruiting)
• Hebei Petro China Center Hospital — Langfang, China (Not_yet_recruiting)
• Liaocheng People's Hospital — Liaocheng, China (Not_yet_recruiting)
• Taian City Central Hospital — Tai'an, China (Not_yet_recruiting)
• W.F. Maternal and Child Health Hospital — Weifang, China (Not_yet_recruiting)
• Yantai Yuhuangding Hospital — Yantai, China (Recruiting)

Study contacts

• Principal investigator: Wei Zhao, Ph.D — Shandong University
• Study coordinator: Wei Zhao, Ph.D

Conditions Late-Onset Neonatal Sepsis; late-onset sepsis; piperacillin/tazobactam; model-based dose; empirical dose