Study identification

PURI

https://redirect.ema.europa.eu/resource/106191

EU PAS number

EUPAS106190

Study ID

106191

Official title and acronym

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

DARWIN EU® study

No

Study countries

Italy

Study description

The infectious diseases surveillance is a key element of early warning systems and preparedness for current and future threats. Acute respiratory viral infections (VARI) cause substantial disease burden, as highlighted not only by COVID-19, but also by other viruses such as influenza and respiratory syncytial virus. These viruses spread mainly in community settings (i.e. schools) and in closed settings characterized by vulnerability of physical (i.e. long-term care facilities) and socioeconomic (i.e. prisons) origin. Environmental characteristics, in particular air quality, and working/living conditions, represent important determinants of diseases. Moreover, the Wastewater Based Epidemiology, extensively used for SARS-CoV2, is now recognized very useful as monitoring and early warning tool. Data coming from both clinical and environmental surveillance of infections are essential to assess the risk, to plan prevention measures and to evaluate their efficacy, but they are affected by bias that could be reduced by integrating them. Funded by the Next Generation EU, our project will consist in creating and testing an Environmental and Clinical Integrated Surveillance System of VARIs and their determinants for communities, using clinical surveillance, environmental monitoring (air, surface and wastewater) and data collection on environmental and behavioral risk factors. In the initial phase of the project, the data collection tools will be designed and validated: questionnaires for symptoms and personal risk factors, separately for the different settings and subjects (e.g. residents and workers), methods for collection and analysis of clinical (swabs) and environmental (air, surfaces and wastewater) samples, integrated database. Furtherly, these tools will be applied in field conditions, data analysis will be performed and, through integration of all information, models will be designed for early warning and for Quantitative Microbial Risk Assessment (QMRA).

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Annalaura Carducci

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Ministero dell'UniversitĂ  e della Ricerca with NextGenerationEU funds
Study protocol
Initial protocol
English (203.2 KB - PDF)View document
Updated protocol
English (513.17 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable