Clinical trial NCT05981079: Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Late-Onset Neonatal Sepsis
Keywords: late-onset sepsis
piperacillin/tazobactam
model-based dose
empirical dose
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
name: Qianfoshan Hospital
name: Jinan Maternity and Child Care Hospital
name: Yantai Yuhuangding Hospital
name: Hebei Petro China Center Hospital
name: Shengli Oilfield Hospital
name: Liaocheng People's Hospital
name: Jining Medical University
name: W.F. Maternal and Child Health Hospital
name: Taian City Central Hospital
First posted: 2023-08-08
Enrollment: 332
Sex: ALL
Minimum age (years): 72
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Successful outcome
timeFrame: At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )
Secondary outcomes:
measure: Length of NICU stay
timeFrame: From the date of randomization until date of discharge, assessed up to 2 months
measure: All cause in-hospital mortality
timeFrame: From the date of randomization until date of discharge, assessed up to 2 months
measure: Proportion of patients switching to or adding another antibiotics.
timeFrame: Through study completion, an average of 20 days.
measure: Relapsed or new infection rate
timeFrame: At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )
measure: PD target attainment
timeFrame: Through study completion, an average of 20 days.
measure: Adverse events
timeFrame: Through study completion, an average of 20 days.
Other outcomes:
Locations:
city: Dongying
country: China
facility: Shengli Oilfield Hospital
city: Jinan
country: China
facility: Jinan Maternity and Child Care Hospital
city: Jinan
country: China
facility: Qianfoshan Hospital
city: Jinan
country: China
facility: Shandong Provincial Hospital
city: Jining
country: China
facility: Jining Medical University
city: Langfang
country: China
facility: Hebei Petro China Center Hospital
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
city: Tai'an
country: China
facility: Taian City Central Hospital
city: Weifang
country: China
facility: W.F. Maternal and Child Health Hospital
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
Study officials:
affiliation: Shandong University
name: Wei Zhao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: