Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.

Late-Onset Neonatal Sepsis Clinical Trial

— PIP/TAZO  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05981079
• Other study ID #: SDU-2023-NeoPIP-002
• Status: Recruiting
• Phase: Phase 4
• Start date: July 31, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: July 2023
• Source: Shandong University
• Contact: Wei Zhao, Ph.D
• Phone: +8653188383308
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 332
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 72 Hours and older

Eligibility

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: ?Patients with a positive baseline blood culture and the pathogen resistant to PIP/TAZO. ?Patients with bacterial meningitis, fungal infection, osteomyelitis, septic arthritis or necrotizing enterocolitis requiring surgery after randomization.

Related Conditions & MeSH terms

• Late-Onset Neonatal Sepsis
• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

Drug:
• Piperacillin/tazobactam
Piperacillin Sodium and Tazobactam Sodium for Injection

Locations

Country	Name	City	State
China	Shengli Oilfield Hospital	Dongying
China	Jinan Maternity and Child Care Hospital	Jinan
China	Qianfoshan 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

Sponsors (11)

Lead Sponsor	Collaborator
Shandong University	Hebei Petro China Center Hospital, Jinan Maternity and Child Care Hospital, Jining Medical University, Liaocheng People's Hospital, Qianfoshan Hospital, Shandong Provincial Hospital, Shengli Oilfield Hospital, Taian City Central Hospital, W.F. Maternal and Child Health Hospital, Yantai Yuhuangding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful outcome	Successful outcome is defined as: Participant is alive.; No need for replacing the antibiotic or adding new antibiotics.; At the end of actual piperacillin/tazobactam therapy, ?there is a significant improvement in the participant's overall clinical status, ?there is microbiological resolution or presumed eradication of bacteria and ?no new piperacillin/tazobactam-susceptible pathogens potentially associated with sepsis have been identified.; Participant does not have a clinically or microbiologically significant relapse or new infection within 10 days after the end of actual piperacillin/tazobactam therapy.	At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )
Secondary	Length of NICU stay	Duration of hospital admission (days)	From the date of randomization until date of discharge, assessed up to 2 months
Secondary	All cause in-hospital mortality	Death before discharge from NICU	From the date of randomization until date of discharge, assessed up to 2 months
Secondary	Proportion of patients switching to or adding another antibiotics.	Proportion of patients switching to or adding another antibiotics by any reason.	Through study completion, an average of 20 days.
Secondary	Relapsed or new infection rate	Proportion of patients with clinically or microbiologically significant relapsed or new infection.	At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )
Secondary	PD target attainment	70%fT>MIC	Through study completion, an average of 20 days.
Secondary	Adverse events	Drug-related adverse events and serious adverse events	Through study completion, an average of 20 days.