Late-Onset Neonatal Sepsis
Conditions
Keywords
late-onset sepsis, piperacillin/tazobactam, model-based dose, empirical dose
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.
Interventions
DRUGPiperacillin/tazobactam
Piperacillin Sodium and Tazobactam Sodium for Injection
Sponsors
Shandong Provincial Hospital
Qianfoshan Hospital
Jinan Maternity and Child Care Hospital
Yantai Yuhuangding Hospital
Hebei Petro China Center Hospital
Shengli Oilfield Hospital
Liaocheng People's Hospital
Jining Medical University
W.F. Maternal and Child Health Hospital
Taian City Central Hospital
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
72 Hours to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Length of NICU stay | From the date of randomization until date of discharge, assessed up to 2 months | Duration of hospital admission (days) |
| PD target attainment | Through study completion, an average of 20 days. | 70%fT\>MIC |
| Adverse events | Through study completion, an average of 20 days. | Drug-related adverse events and serious adverse events |
| 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. |
Countries
China
Contacts
Primary ContactWei Zhao, Ph.D
Outcome results
None listed