Integrated environmental and Integrated environmental and clinical surveillance for the prevention of acute respiratory infections (ARIs) in closed settings and vulnerable communities (Stell-ARI)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Environmental monitoring, Active surveillance

Study drug and medical condition

• Medical condition to be studied:
  COVID-19

  SARS-CoV-2 test

  Influenza

  Adenovirus infection

  Respiratory syncytial virus infection

  Environmental exposure

  Influenza like illness
• Additional medical condition(s):
  Environmental characteristics: general characteristics of the facility, daily activities performed, hygiene rules followed in the facility. Individual characteristics: general characteristics of the individual, general pathology of the subject including respiratory and allergic pathology, vaccination status, exposure to risk factors, socio-economic factors, acute pathology during the study period.

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The aim of this study is to create an integrated clinical and environmental surveillance system of VARIs and its determinants in community settings in order to plan prevention strategies and interventions to minimize the spread of infections.
• Outcomes:
  Integration of clinical, behavioural and environmental data to develop early warning and risk prediction models that can be transferred to similar communities at the regional/national/international levels. 1. Establishment of sentinel clinical surveillance and risk factors for VARI in selected closed environments for the detection of specific respiratory diseases and their evolution. 2. Establishment of sentinel environmental surveillance in closed environments on the basis of environmental parameters, indoor air quality monitoring, microbiological monitoring of wastewater.
• Data analysis plan:
  Subject characteristics will be described by means of medians and interquartile ranges for numerical variables and absolute frequencies and percentages for categorical variables. The time course of the environmental variables will be represented by means of graphical displays and spline regression models will be used to estimate their time course. The association between infections detected by nasopharyngeal swabs/questionnaires and exposure factors will be assessed by means of logistic regression models that take possible confounders into account. QMRA models will be developed, and Monte Carlo Analysis will be applied through Vensim software. The relationship between ARI incidence and environmental data will be investigated by means of time series regression models. Analyses will encompass the entire dataset or be stratified based on different settings. Statistical tests will be two-sided with a significance level set at α = 0.05. Data will be analysed with the statistical software R.