Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.
- Conditions
- Late-Onset Neonatal Sepsis
- Interventions
- Drug: Piperacillin/tazobactam
- Registration Number
- NCT05981079
- Lead Sponsor
- Shandong University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 332
- Preterm neonates: gestational age <34 weeks;
- Postnatal age > 72h;
- Postmenstrual age <36 weeks;
- Newly diagnosed as late-onset sepsis;
- Parental written consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Empirical dosing regimen Piperacillin/tazobactam Drug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: 90 mg/kg，Q8H. Model-based dosing regimen Piperacillin/tazobactam 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.
- Primary Outcome Measures
Name Time Method Successful outcome 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.
- Secondary Outcome Measures
Name Time Method All cause in-hospital mortality From the date of randomization until date of discharge, assessed up to 2 months Death before discharge from NICU
Proportion of patients switching to or adding another antibiotics. Through study completion, an average of 20 days. Proportion of patients switching to or adding another antibiotics by any reason.
Relapsed or new infection rate At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy ) Proportion of patients with clinically or microbiologically significant relapsed or new infection.
Length of NICU stay From the date of randomization until date of discharge, assessed up to 2 months Duration of hospital admission (days)
Adverse events Through study completion, an average of 20 days. Drug-related adverse events and serious adverse events
PD target attainment Through study completion, an average of 20 days. 70%fT\>MIC
Trial Locations
- Locations (10)
Qianfoshan Hospital
🇨🇳Jinan, China
Shengli Oilfield Hospital
🇨🇳Dongying, China
Jinan Maternity and Child Care Hospital
🇨🇳Jinan, China
Shandong Provincial Hospital
🇨🇳Jinan, China
Jining Medical University
🇨🇳Jining, China
Hebei Petro China Center Hospital
🇨🇳Langfang, China
Liaocheng People's Hospital
🇨🇳Liaocheng, China
Taian City Central Hospital
🇨🇳Tai'an, China
W.F. Maternal and Child Health Hospital
🇨🇳Weifang, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, China