Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-o… (NCT05981079) | Clinical Trial Compass
UnknownPhase 4
Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.
China332 participantsStarted 2023-07-31
Plain-language 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.
Who can participate
Age range72 Hours
SexALL
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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: â‘ Patients with a positive baseline blood culture and the pathogen resistant to PIP/TAZO. â‘¡Patients with bacterial meningitis, fungal infection, osteomyelitis, septic arthritis or necrotizing enterocolitis requiring surgery after randomization.
What they're measuring
1
Successful outcome
Timeframe: At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )