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临床试验/NCT04388293
NCT04388293招募中不适用

Using Antibiotics Wisely - Development of National Neonatal Intensive Care Unit-specific ASP

University of British Columbia1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
1
主要终点
Prevalence of multi-drug resistant organisms in infections among very-low-birth-weight neonates during their NICU stay

研究概览

简要总结

There are significant variations in antimicrobial consumption across Canadian Neonatal Intensive Care Units (NICUs). Inappropriate and overuse of antibiotics can result in antimicrobial resistance and adverse outcomes among vulnerable neonatal populations. There are limited data on broad-spectrum antimicrobial use, multi-drug resistant organisms (MDRO) prevalence, and effective NICU-specific antimicrobial stewardship strategies. The aim of this study is to develop and implement NICU-specific antimicrobial stewardship strategies at both national and individual unit levels to promote optimal antimicrobial use and decrease the incidence of MDROs.

详细描述

Purpose: The investigators aim to develop and implement NICU-specific Antimicrobial Stewardship Program (ASP) strategies at both national and individual unit levels to promote optimal antimicrobial use and decrease the incidence of multi-drug resistant organisms (MDRO) in Canada.

Hypothesis

The investigators expect to find:

  • Significant national variation in broad-spectrum antimicrobial use, which will not be correlated with rates of sepsis. High antimicrobial consumption rates may be associated with limited existing ASP resources and increased neonatal morbidity related to inflammatory cascades.
  • Significant national variation in the prevalence of MDROs across NICUs.
  • Differences in empirical antimicrobial regimens may be associated with MDRO prevalence, and the variation in antimicrobial use may explain some variation in neonatal morbidity.

Study Population and Sample Size: The study population will include very-low-birth-weight (VLBW) infants (i.e., the group of infants neonates with the highest risk of infections within NICUs) admitted to participating tertiary NICUs in Canada.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
22 Weeks 至 44 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Very-low-birth-weight infants admitted to participating tertiary NICUs in Canada.

排除标准

  • infants with major congenital anomalies

结局指标

主要结局

Prevalence of multi-drug resistant organisms in infections among very-low-birth-weight neonates during their NICU stay

时间窗: 2020-2025

Days of therapy/1000 patient-day of each category of antimicrobial consumption

时间窗: 2020-2025

次要结局

  • Association between multi-drug resistant organisms, broad-spectrum antimicrobial use, neonatal outcomes and existing Antimicrobial Stewardship Programs & screening policies.(2020-2025)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Ting

Principal Investigator

University of Alberta

研究点 (1)

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