跳至主要内容
临床试验/NCT04172610
NCT04172610已完成不适用

The Prevalence of Influenza Related Invasive Aspergillosis in Swedish Intensive Care Units

Karolinska University Hospital10 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2019年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
10
主要终点
Prevalence of proven or probable invasive pulmonary aspergillosis

研究概览

简要总结

This is a multicenter study with the aim to determine the prevalence of influenza-related invasive pulmonary aspergillosis in Swedish intensive care units and to assess the clinical impact of and risk factors for influenza-related invasive pulmonary aspergillosis

详细描述

This is a multicenter prospective observational study conducted at 12 intensive care units (ICU) in Sweden. All patients >18 years of age with a Polymerase Chain Reaction (PCR)-verified influenza A or B diagnosed up to 7 days before admission to the ICU or during ICU care, will be included in the study.

A new clinical routine has been implemented at the study centers: During the ICU stay screening with Beta-D-glucan and Galactomannan in blood/serum will be performed twice weekly and a respiratory sample will be retrieved for fungal culture and microscopy once weekly.

All results from collected samples will be available to the patient's attending physicians. Clinical and microbiological data will be collected, and the diagnosis of invasive aspergillosis will be made using predefined diagnostic criteria.

Objectives:

  1. To determine the prevalence of influenza-related invasive pulmonary aspergillosis in Swedish intensive care units
  2. To assess the clinical impact of and risk factors for influenza-related invasive pulmonary aspergillosis

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed influenza A or B diagnosed up to 7 days before ICU admission, or during ICU care
  • Admitted to the ICU

排除标准

  • Under 18 years of age

结局指标

主要结局

Prevalence of proven or probable invasive pulmonary aspergillosis

时间窗: From date of enrollment up to 90 days after enrollment

Enrolled patients will be categorized as proven or probable invasive pulmonary aspergillosis at discharge from the ICU.

次要结局

  • Sequential Organ Failure assessment Score (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)(from date of admission to ICU to date of discharge from ICU, approximately 21 days)
  • Use of mechanical ventilation (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)(from date of admission to ICU to date of discharge from ICU, approximately 21 days)
  • Use of non-invasive ventilation (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)(from date of admission to ICU to date of discharge from ICU, approximately 21 days)
  • Use of vasopressor (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)pulmonary aspergillosis and those that were not)(from date of admission to ICU to date of discharge from ICU, approximately 21 days)
  • Use of renal replacement therapy (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)(from date of admission to ICU to date of discharge from ICU, approximately 21 days)
  • Acute Respiratory Distress Syndrome (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)(from date of admission to ICU to date of discharge from ICU, approximately 21 days)
  • Days of ICU stay (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)(from date of admission to ICU to date of discharge from ICU, approximately 21 days)
  • ICU mortality (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)(from date of admission to ICU to date of discharge from ICU, approximately 21 days)
  • 90-day mortality after ICU admission (in patients diagnosed with proven/probable invasive pulmonary aspergillosis and those that were not)(from date of ICU admission to 90 days after ICU admission)

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anders Krifors

Principal Investigator

Karolinska University Hospital

研究点 (10)

Loading locations...

相似试验