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临床试验/NL-OMON49786
NL-OMON49786已完成不适用

Multi-centre EuRopean study of MAjor Infectious Disease Syndromes (MERMAIDS) * Acute Respiratory Infections (MERMAIDS ARI) 2.0 - MERMAIDS-ARI 2.0

niversitair Medisch Centrum Utrecht0 个研究点目标入组 50 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
2 至 99(—)

入选标准

  • Patient is admitted to hospital and fulfills selection criteria A or B and
  • should be able to be enrolled in the study within 48 hours after fulfilling the
  • eligibility criteria :
  • A. Patients of all ages with respiratory symptoms as reason for admission Upon
  • admission, all of the following:
  • 1. Clinical suspicion of a new episode of acute respiratory tract infection
  • with a high probability of COVID19 diagnosis (eg. based on epidemiological
  • linkage or diagnostic procedures ).
  • 2. Primary reason for hospital admission is clinical suspicion of a new episode
  • 3. Onset of the following symptoms within the time window of last 14days: i.
  • Sudden onset of self-reported fever OR temperature of * 38°C at presentation
  • AND ii. At least one respiratory symptom (cough, sore throat, runny or
  • congested nose, dyspnea) AND iii. At least one systemic symptom (headache,
  • muscle ache, sweats or chills or tiredness).
  • B. Patients without respiratory symptoms as reason for admission, one of the
  • 1. Patients of all ages who have a Laboratory confirmed SARS-CoV-2 infection at
  • the time of eligibility check. Microbiological diagnosis should be confirmed by
  • molecular testing. If additional tests such as antigen detection are validated
  • and available at the time of inclusion, it should be confirmed by a reference
  • This allows for additional identification of 1) severe COVID-19 cases
  • presenting to care but without fever, and 2) nosocomial cases of COVID-19
  • 2. In In patients <18 years of age only:
  • Positive serology (and/or PCR-test) for SARS-CoV-2 AND Clinical suspicion of
  • Paediatric Inflammatory Multi-system Syndrome * temporally associated with
  • SARS-CoV 2 (PIMS-TS):
  • https://picsociety.uk/wp-content/uploads/2020/05/PIMS-TS-Critical-Care-Clinical-
  • Guidance-v4.pdf

排除标准

  • 1.Inability to obtain consent from patient or representative
  • 2.Patient transferred from another hospital ,being hospitalized for over 48
  • hours in total (applicable to patients with respiratory symptoms as reason for
  • admission) ,
  • Participation in an interventional study or other observational study will not
  • be considered an exclusion criteria

研究者

发起方
niversitair Medisch Centrum Utrecht

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