Status:
UNKNOWN
Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.
Lead Sponsor:
Shandong University
Collaborating Sponsors:
Shandong Provincial Hospital
Qianfoshan Hospital
Conditions:
Late-Onset Neonatal Sepsis
Eligibility:
All Genders
72+ years
Phase:
PHASE4
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, s...
Eligibility Criteria
Inclusion
- Preterm neonates: gestational age \<34 weeks;
- Postnatal age \> 72h;
- Postmenstrual age \<36 weeks;
- Newly diagnosed as late-onset sepsis;
- Parental written consent.
Exclusion
- 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.
Key Trial Info
Start Date :
July 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT05981079
Start Date
July 31 2023
End Date
May 31 2025
Last Update
August 8 2023
Active Locations (10)
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1
Shengli Oilfield Hospital
Dongying, China
2
Jinan Maternity and Child Care Hospital
Jinan, China
3
Qianfoshan Hospital
Jinan, China
4
Shandong Provincial Hospital
Jinan, China