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

NCT05981079 | Unknown Phase 4

• 1 other identifier: SDU-2023-NeoPIP-002
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 10

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.

Conditions

Late-Onset Neonatal Sepsis

Keywords

late-onset sepsis; piperacillin/tazobactam; model-based dose; empirical dose

Outcome Measures

Primary Outcomes (1)

• Successful outcome

  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.

  At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )

Secondary Outcomes (6)

• Length of NICU stay

  From the date of randomization until date of discharge, assessed up to 2 months

• All cause in-hospital mortality

  From the date of randomization until date of discharge, assessed up to 2 months

• Proportion of patients switching to or adding another antibiotics.

  Through study completion, an average of 20 days.

• Relapsed or new infection rate

  At the follow-up visit (10 ± 1 days after the end of actual piperacillin/tazobactam therapy )

• PD target attainment

  Through study completion, an average of 20 days.

Study Arms (2)

Model-based dosing regimen

EXPERIMENTAL

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/tazobactam

Empirical dosing regimen

ACTIVE COMPARATOR

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

Drug: Piperacillin/tazobactam

Interventions

Piperacillin/tazobactam DRUG

Piperacillin Sodium and Tazobactam Sodium for Injection

Empirical dosing regimen; Model-based dosing regimen

Eligibility Criteria

• Age: 72 Hours+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preterm neonates: gestational age \<34 weeks;
• Postnatal age \> 72h;
• Postmenstrual age \<36 weeks;
• Newly diagnosed as late-onset sepsis;
• Parental written consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (10)

Shengli Oilfield Hospital

Dongying, China

NOT YET RECRUITING

Jinan Maternity and Child Care Hospital

Jinan, China

NOT YET RECRUITING

Qianfoshan Hospital

Jinan, China

NOT YET RECRUITING

Shandong Provincial Hospital

Jinan, China

NOT YET RECRUITING

Jining Medical University

Jining, China

NOT YET RECRUITING

Hebei Petro China Center Hospital

Langfang, China

NOT YET RECRUITING

Liaocheng People's Hospital

Liaocheng, China

NOT YET RECRUITING

Taian City Central Hospital

Tai’an, China

NOT YET RECRUITING

W.F. Maternal and Child Health Hospital

Weifang, China

NOT YET RECRUITING

Yantai Yuhuangding Hospital

Yantai, China

RECRUITING

MeSH Terms

Conditions

Neonatal Sepsis

Interventions

Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Wei Zhao, Ph.D

  Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Zhao, Ph.D

CONTACT

+8653188383308; zhao4wei2@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of clinical pharmacy and pharmacology

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 8, 2023
• Study Start: July 31, 2023
• Primary Completion: December 31, 2024
• Study Completion: May 31, 2025
• Last Updated: August 8, 2023

Record last verified: 2023-07

Locations

CN (10)