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临床试验/NCT05620953
NCT05620953已完成不适用

Severe Acute Respiratory Infections Surveillance in Belgium (2011-2020, Prior to COVID-19 Pandemic)

Sciensano0 个研究点目标入组 12,145 人开始时间: 2012年1月20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
Sciensano
入组人数
12,145
主要终点
Number of participants positive for influenza viruses

研究概览

简要总结

The Belgian Severe Acute Respiratory Infections network (BELSARI-net) was implemented during the influenza season 2011-2012 following the recommendations of the World Health Organization (WHO) to monitor severity of influenza viruses in hospitals. The network is composed of 6 hospitals throughout the country, two in each administrative region (Flanders, Wallonia and Brussels-Capital), and operates during the influenza epidemic period (from the last week of December or first/second week of January to the third/last week of April, depending on when influenza virus circulation is detected by the general population, based on the Influenza-like illness (ILI) network of general practitioners).

Enrollment is performed for all cases matching the SARI case definition (based on WHO's case definition) and accepting to take part. A respiratory specimen is sampled systematically from each participant, and detailed clinico-epidemiological data, such as information on age, sex, symptoms and potential risk factors such as pregnancy or comorbidities (chronic respiratory diseases, asthma, chronic cardiovascular diseases, renal insufficiency, obesity, diabetes, hepatic or renal insufficiency, immunodeficiency, neuromuscular disease, pregnancy) is also collected. Participants are followed up during hospitalization for the occurrence of complications (detection of pneumonia based on chest radiography, development of acute respiratory distress syndrome (ARDS), requirement for respiratory assistance and/or for extracorporeal membrane oxygenation (ECMO), admission in intensive care unit (ICU)), or death (all-cause death).

The current project includes all the samples received by the Belgian National Influenza Centre (NIC) during the influenza seasons 2011-2012 till 2019-2020.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All pediatric and adult patients admitted to one of the 6 sentinel hospitals during the active surveillance and fulfilling the case definition of acute respiratory infection with onset within the last ten days, with history of fever or measured fever of ≥38°C, with cough and/or dyspnea, and overnight hospitalization.

排除标准

  • nosocomial infection, i.e. symptoms appearing after admission

结局指标

主要结局

Number of participants positive for influenza viruses

时间窗: within 10 days after symptom onset

result of influenza PCR detection test (typing and subtyping)

Number of participants positive for non-influenza viruses

时间窗: within 10 days after symptom onset (only routinely tested since influenza season 2015-2016)

results of non-influenza multiplex PCR detection test (16 targets)

Number of participants who died during hospitalization

时间窗: from date of hospital admission until date of death during hospitalization or date of hospital exit

alive or dead

次要结局

  • Number of participants with at least one known risk factor(on date of hospital admission)
  • Number of participants who experienced at least one complication(from date of hospital admission until date of death during hospitalization or date of hospital exit)

研究者

发起方
Sciensano
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Cyril Barbezange

scientist

Sciensano

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