NCT06649032

Survey of Incidence of Respiratory Tract Infections

A Multicentric Epidemiological Study of the Actual Incidence of Respiratory Tract Infections in an Adult Italian Population, With or Without Underlying Risk Factors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,736 (actual)
• Sponsor: Lallemand Pharma AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to acquire reliable and current data on the actual incidence (post-COVID) of respiratory tract infections in the general adult population in the absence of any intervention. These data will provide useful background information for designing future studies aimed at assessing whether preventive measures or pharmacological treatments are beneficial in reducing the frequency and severity of infectious episodes.

Detailed description

This multicentric prospective observational survey will be carried out in Italy during the winter and early spring ( December 22nd to April 30th) in two consecutive years on approximately 2750 subjects recruited in the period between November 1st and December 21st in different medical settings and regions. Investigators from 4 different institutions will be involved: FIMMG (Federazione Italiana dei Medici di Medicina Generale). Ten general practitioners will recruit approx. 1000 consecutive subjects from the general population. SIAAIC (Societa' Italiana di Allergologia, Asma e Immunologia Clkinica). Ten allergy specialists will recruit approx.1000 consecutive subjects suffering from allergic diseases. Fondazione Maugeri (5 Centers) and UCSC (Universita' Cattolica del Sacro Cuore) / Policlinico Gemelli will recruit approx. 750 consecutive subjects suffering from asthma or COPD. Participants having signed an informed consent at any suspected Respiratory Tract Infection (RTI) during the observation period will be asked to contact (phone call or visit) the investigator to record the relevant clinical information documenting the RTI episode. At the end of the observation period all subjects will be contacted by the investigators to check for completeness and compliance of the RTI reporting. The procedure will be repeated in the same way in the second year of survey but including subjects having experienced at least one confirmed RTI during the first year. This will allow assessing intra-individual variability of infectious episodes from year to year.

Conditions

• Healthy Adults
• Not Healthy Adults

Interventions

Type	Name	Description
OTHER	No intervention	no difference: both cohorts are followed in the same way

Timeline

• Start date: 2023-11-07
• Primary completion: 2025-05-31
• Completion: 2025-07-17
• First posted: 2024-10-18
• Last updated: 2025-08-11

Locations

23 sites across 1 country: Italy