U04
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Willing and able to provide informed consent, when applicable, obtained from the patient or from the patient’s Legally Acceptable Representative(s) (LAR)
Exclusion criteria
Exclusion criteria: Exclusion: only for sites in the United Kingdom: deemed mentally incapacitated to provide informed consent due to a condition other than SARI, as defined by the UK Mental Capacity Act 2025». For other sites, no exclusion criteria have been defined.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This surveillance study aims to establish active surveillance for hospitalised SARI cases in adults in Europe. The primary objectives are: 1. To calculate the proportion of laboratory samples positive for each viral respiratory pathogen of interest (footnote 1), among adult patients hospitalised with SARI; 2. To characterise adult SARI patients (including age, gender, protective- and risk factors, specific treatments, healthcare utilisation outcomes (footnote 2)), overall and by viral respiratory pathogen of interest (footnote 1). Footnotes: (1) SARS-CoV-2, Influenza A/B, Respiratory Syncytial Virus (RSV) A/B, Adenovirus, Parainfluenza viruses (1-4), human metapneumovirus (hMPV), human rhinovirus (HRV), human enterovirus (HEV), human coronaviruses (229E/NL63/OC43/HKU1), and human bocavirus (1-4). (2) Healthcare utilisation outcomes are defined by outcome (hospitalisation without ICU admission or in-hospital death; ICU admission without in-hospital death; in-hospital death), by the need for respiratory support (none; non-invasive ventilation; mechanical ventilation; ECMO), discharge destination and length of stay. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: 3. To investigate the prevalence of co-infection with the viral respiratory pathogens of interest (footnote 1), in adult patients hospitalised with SARI, and the impact on healthcare utilisation outcomes (footnote 2). 4. To explore risk factors of pathogen-specific SARI (footnote 3), healthcare utilisation outcomes and the presence of co-infection. Exploratory objectives are: 5. To calculate pathogen-specific SARI incidences and describe trends in adults (by time period, country, and level of severity); 6. To perform feasibility assessments for future respiratory disease studies within the id.DRIVE Study Network (e.g., effectiveness studies, impact studies). Footnotes: (1) SARS-CoV-2, Influenza A/B, Respiratory Syncytial Virus (RSV) A/B, Adenovirus, Parainfluenza viruses (1-4), human metapneumovirus (hMPV), human rhinovirus (HRV), human enterovirus (HEV), human coronaviruses (229E/NL63/OC43/HKU1), and human bocavirus (1-4). (2) Healthcare utilisation outcomes are defined by outcome (hospitalisation without ICU admission or in-hospital death; ICU admission without in-hospital death; in-hospital death), by the need for respiratory support (none; non-invasive ventilation; mechanical ventilation; ECMO), discharge destination and length of stay. (3) Factors associated with an infection by pathogen of interest versus not being infected by the pathogen of interest among adult patients hospitalised with SARI. | — |
Countries
France, Germany, Italy, Spain, United Kingdom
Contacts
P95 Clinical & Epidemiology Services