Study type

Study topic

Disease /health condition

Study topic, other

Surveillance of respiratory pathogens in Europe

Study type

Non-interventional study

Scope of the study

Disease epidemiology

Data collection methods

Combined primary and secondary data collection
Non-interventional study

Non-interventional study design

Other
Study drug and medical condition

Medical condition to be studied

Severe acute respiratory syndrome
Population studied

Short description of the study population

Adults aged 18 years and older (patients), presenting at the participating hospitals during the study period, who are willing and able to provide informed consent (or alternatively, informed consent is obtained form the patient´s legally acceptable representatitve) AND who are hospitalised and meet the SARI patient definition.

A SARI patient is defined as a hospitalised person with a suspicion of a respiratory infection with at least one of the following symptoms:
• cough
• fever (≥ 38 C°)
• shortness of breath
• sudden onset of anosmia, ageusia or dysgeusia
with symptom onset within the last 14 days prior to hospital admission.

Age groups

Adult and elderly population (>18 years)
Adults (18 to < 65 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Elderly (≥ 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)
Study design details

Study design

Non-interventional multi-country, multi-centre, hospital-based surveillance study.

Main study objective

This surveillance study aims to establish active surveillance for hospitalised SARI cases in adults in Europe.
Primary objectives:
1. Proportion of laboratory samples positive for each viral respiratory pathogen of interest
2. Characterisation of adult SARI patients overall and by pathogen

Setting

Hospitals

Outcomes

The outcome of interest for the primary objectives will be laboratory-confirmed infection with one of the viral respiratory pathogens of interest in patients hospitalised with SARI symptoms, and laboratory-confirmed co-infection for the secondary objective (prevalence of co-infection with the viral respiratory pathogens of interest, in adult patients hospitalised with SARI, and the impact on healthcare utilisation outcomes [level of severity, hospital discharge destination, length of hospital stay]).
Pathogen-specific SARI incidences will be calculated to address the first exploratory objective (pathogen-specific SARI incidences and description of trends in hospitalised adults [time period, country, level of severity]). The denominator will be based on the sum of the catchment populations covered by the Study Contributors.
For the second exploratory objective, feasibility assessments for future respiratory disease impact and effectiveness studies will be made.

Data analysis plan

A statistical analysis plan (SAP) is developed prior to the conduct of the analysis. The SAP specifies all statistical analyses, including sensitivity analyses, to be conducted and includes table shells and mock figures.