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.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 332
- 试验地点
- 10
- 主要终点
- Successful outcome
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 72 Hours 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates: gestational age <34 weeks;
- •Postnatal age > 72h;
- •Postmenstrual age <36 weeks;
- •Newly diagnosed as late-onset sepsis;
- •Parental written consent.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Piperacillin/tazobactam (Drug)
Empirical dosing regimen
Drug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: 90 mg/kg，Q8H.
干预措施: Piperacillin/tazobactam (Drug)
结局指标
主要结局
Successful outcome
时间窗: At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )
Successful outcome is defined as: 1. Participant is alive. 2. No need for replacing the antibiotic or adding new antibiotics. 3. At the end of actual piperacillin/tazobactam therapy, ①there is a significant improvement in the participant's overall clinical status, ②there is microbiological resolution or presumed eradication of bacteria and ③no new piperacillin/tazobactam-susceptible pathogens potentially associated with sepsis have been identified. 4. Participant does not have a clinically or microbiologically significant relapse or new infection within 10 days after the end of actual piperacillin/tazobactam therapy.
次要结局
- All cause in-hospital mortality(From the date of randomization until date of discharge, assessed up to 2 months)
- Proportion of patients switching to or adding another antibiotics.(Through study completion, an average of 20 days.)
- Relapsed or new infection rate(At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy ))
- Length of NICU stay(From the date of randomization until date of discharge, assessed up to 2 months)
- Adverse events(Through study completion, an average of 20 days.)
- PD target attainment(Through study completion, an average of 20 days.)
研究者
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University