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

Primary Purpose

Late-Onset Neonatal Sepsis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Piperacillin/tazobactam
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Late-Onset Neonatal Sepsis focused on measuring late-onset sepsis, piperacillin/tazobactam, model-based dose, empirical dose

Eligibility Criteria

72 Hours - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Model-based dosing regimen

Empirical dosing regimen

Arm Description

Drug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: GA<28 weeks: 30 mg/kg, Q8H; 28 weeks ≤GA<34 weeks: 50 mg/kg，Q8H.

Drug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: 90 mg/kg，Q8H.

Outcomes

Primary Outcome Measures

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, 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. 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 Outcome Measures

Length of NICU stay
Duration of hospital admission (days)
All cause in-hospital mortality
Death before discharge from NICU
Proportion of patients switching to or adding another antibiotics.
Proportion of patients switching to or adding another antibiotics by any reason.
Relapsed or new infection rate
Proportion of patients with clinically or microbiologically significant relapsed or new infection.
PD target attainment
70%fT>MIC
Adverse events
Drug-related adverse events and serious adverse events

Full Information

First Posted
July 14, 2023
Last Updated
July 31, 2023
Sponsor
Shandong University
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05981079
Brief Title
Model-based Dose Versus Empirical Dose of Piperacillin/Tazobactam in Preterm Neonates With Late-onset Sepsis.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Late-Onset Neonatal Sepsis
Keywords
late-onset sepsis, piperacillin/tazobactam, model-based dose, empirical dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
332 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Model-based dosing regimen
Arm Type
Experimental
Arm Description
Drug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: GA<28 weeks: 30 mg/kg, Q8H; 28 weeks ≤GA<34 weeks: 50 mg/kg，Q8H.
Arm Title
Empirical dosing regimen
Arm Type
Active Comparator
Arm Description
Drug: Piperacillin Sodium and Tazobactam Sodium for Injection. Dosing regimen: 90 mg/kg，Q8H.
Intervention Type
Drug
Intervention Name(s)
Piperacillin/tazobactam
Intervention Description
Piperacillin Sodium and Tazobactam Sodium for Injection
Primary Outcome Measure Information:
Title
Successful outcome
Description
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, 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. Participant does not have a clinically or microbiologically significant relapse or new infection within 10 days after the end of actual piperacillin/tazobactam therapy.
Time Frame
At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )
Secondary Outcome Measure Information:
Title
Length of NICU stay
Description
Duration of hospital admission (days)
Time Frame
From the date of randomization until date of discharge, assessed up to 2 months
Title
All cause in-hospital mortality
Description
Death before discharge from NICU
Time Frame
From the date of randomization until date of discharge, assessed up to 2 months
Title
Proportion of patients switching to or adding another antibiotics.
Description
Proportion of patients switching to or adding another antibiotics by any reason.
Time Frame
Through study completion, an average of 20 days.
Title
Relapsed or new infection rate
Description
Proportion of patients with clinically or microbiologically significant relapsed or new infection.
Time Frame
At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )
Title
PD target attainment
Description
70%fT>MIC
Time Frame
Through study completion, an average of 20 days.
Title
Adverse events
Description
Drug-related adverse events and serious adverse events
Time Frame
Through study completion, an average of 20 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zhao, Ph.D
Phone
+8653188383308
Email
zhao4wei2@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhao, Ph.D
Organizational Affiliation
Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shengli Oilfield Hospital
City
Dongying
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihua Liu
Facility Name
Jinan Maternity and Child Care Hospital
City
Jinan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenwen Zhang
Facility Name
Qianfoshan Hospital
City
Jinan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dejuan Yang
Facility Name
Shandong Provincial Hospital
City
Jinan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonghui Yu
Facility Name
Jining Medical University
City
Jining
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ru Yang
Facility Name
Hebei Petro China Center Hospital
City
Langfang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huan Li
Facility Name
Liaocheng People's Hospital
City
Liaocheng
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Zhao
Facility Name
Taian City Central Hospital
City
Tai'an
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo Yao
Facility Name
W.F. Maternal and Child Health Hospital
City
Weifang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Zhou
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanshan Hou

12. IPD Sharing Statement

Learn more about this trial

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

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