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临床试验/NCT05314816
NCT05314816已完成不适用

Clinical Impact of a Multiplex PCR Blood Culture Identification Panel in Early Identification of Positive Blood Cultures in Pediatric Patients in Guatemala

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 479 人开始时间: 2022年4月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
479
试验地点
1
主要终点
Time to Optimal Antimicrobial Therapy

研究概览

简要总结

The purpose of this study is to assess the clinical impact of a rapid multiplex PCR blood culture identification panel on time to optimal antimicrobial therapy when compared to conventional microbiological culture methods in children hospitalized in a low resource setting in Guatemala City.

详细描述

A retrospective review of positive blood cultures was performed on pediatric patients at a tertiary hospital in Guatemala City. These will serve as retrospective controls. The prospective portion of this study will implement the BioFire FilmArray blood culture identification panel (BCID2). Laboratory technicians will perform BCID2 simultaneously with standard culture after it flags positive on the automated blood culture system. BCID2 will be performed on those blood culture specimens that become positive during normal laboratory daytime working hours. Those specimens that become positive overnight will not have the BCID2 performed and will serve as concurrent controls. Physicians will be notified of panel results for the BCID2 intervention group and standard culture results per current laboratory protocol. This study will compare time to optimal antimicrobial therapy (primary outcome), as well as secondary outcome measures, between the intervention group and the 2 control groups.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age <18 years of age
  • First positive blood culture during the hospitalization

排除标准

  • Non-blood specimens
  • Repeat positive blood cultures from the same admission
  • Patients who expire prior to positive culture
  • Outpatient blood cultures

结局指标

主要结局

Time to Optimal Antimicrobial Therapy

时间窗: 14 days

Calculated from the time of blood culture draw to the time that optimal antimicrobial therapy is started. Optimal antimicrobial therapy is defined based on pre-determined organism-antimicrobial guidelines.

次要结局

  • Time to Effective Antimicrobial Therapy(14 days)
  • Intensive Care Unit Days(30 days)
  • Time to Organism Identification(14 days)
  • Length of Hospital Stay(30 days)
  • All-cause Mortality(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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