Clinical trial NCT06649032: Survey of Incidence of Respiratory Tract Infections
Official title: A Multicentric Epidemiological Study of the Actual Incidence of Respiratory Tract Infections in an Adult Italian Population, with or Without Underlying Risk Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Adults
Not Healthy Adults
Keywords: incidence
adults
respiratory tract infections
Lead sponsor: Lallemand Pharma AG
Sponsor class: INDUSTRY
Collaborators: name: Istituto di Farmacologia Traslazionale - National Research Council (IFT-CNR)
First posted: 2024-10-18
Enrollment: 2750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: During both enrolment periods, the study participation will be proposed to adults (without risk factors for respiratory tract infections or with risk factor, e.g. asthma, allergy, COPD) visiting their practitioner for any medical reason. During the observation periods, the subjects who accept study participation will report respiratory tract infections to the investigators.

Brief 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.

Eligibility criteria: Inclusion Criteria:

Male or female aged from at least 18 years -

Exclusion Criteria:

Minor subjects-

Primary outcomes:
measure: Incidence of respiratory tract infections during the whole observation period (whole population, with risk factor, without risk factor)
timeFrame: From 22nd Dec 2023 to 30th Apr2024 and from 22nd Dec 2024 to 30th Apr 2025
Secondary outcomes:
measure: Number of subjects of the Cohort Incidence with at least one respiratory tract infection during the first observation period (whole population, with risk factor, without risk factor)
timeFrame: from 22nd Dec 2023 to 30th Apr 2024
measure: Number of subjects of the Cohort Incidence with at least one respiratory tract infection during the second observation period (whole population, with risk factor, without risk factor)
timeFrame: from 22nd Dec 2024 to 30th Apr 2025
measure: Number of subjects from the Cohort RTI positive who had at least one respiratory tract infection during the second observation period
timeFrame: From 22nd Dec 2024 to 30th Apr 2025
measure: Total and mean number of respiratory tract infections during the first observation period for subjects belonging to the Cohort Incidence (whole population, with risk factor, without risk factor)
timeFrame: from 22nd Dec 2023 to 30th Apr 2024
measure: Total and mean number of respiratory tract infections during the second observation period for subjects belonging to the Cohort Incidence (whole population, with risk factor, without risk factor)
timeFrame: from 22nd Dec 2024 to 30th Apr 2025
measure: Comparaison of the mean number of respiratory tract infections during the first observation period versus the second one for subjects belonging to the Cohort RTI positive (whole population, with risk factor, without risk factor)
timeFrame: from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
measure: Total and mean number of respiratory tract infections during the first observation period for subjects belonging to the Cohort RTI positive (whole population, with risk factor, without risk factor
timeFrame: from 22nd Dec 2023 to 30th Apr 2024
measure: Total and mean number of respiratory tract infections during the second observation period for subjects belonging to the Cohort RTI positive (whole population, with risk factor, without risk factor)
timeFrame: from 22nd Dec 2024 to 30th Apr 2025
measure: Total and mean number of respiratory tract infections during the whole observation period for subjects belonging to the Cohort RTI positive (whole population, with risk factor, without risk factor)
timeFrame: from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
measure: Time to first respiratory infection during the first observation period (whole population, with risk factor, without risk factor) for subjects of the Cohort Incidence
timeFrame: from 22nd Dec 2023 to 30th Apr 2024
measure: Time to first respiratory infection of the subjects belonging to the Cohort Incidence during the second observation period (whole population, with risk factor, without risk factor
timeFrame: from 22nd Dec 2024 to 30th Apr 2025
measure: Time to first respiratory tract infection in the subjects belonging to the Cohort Incidence during the whole observation period (whole population, with risk factor, without risk factor
timeFrame: 023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025 from 22nd Dec 2
measure: Comparaison of the mean number of respiratory tract infections during the first observation period versus the second one for subjects belonging to the Cohort Incidence (whole population, with risk factor, without risk factor)
timeFrame: from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
measure: Number of subjects of the Cohort RTI positive with recurrent respiratory tract infections (≥2) during each consecutive observation period (whole population, with risk factor, without risk factor)
timeFrame: from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
measure: Number of subjects in both cohorts who were treated with antibiotics/antivirals during respiratory tract infections of the whole observation period (whole population, with risk factor, without risk factor)
timeFrame: from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
measure: Number of subjects in both cohorts who were treated with antibiotics/antivirals during respiratory tract infections of the first observation period (whole population, with risk factor, without risk factor)
timeFrame: from 22nd Dec 2023 to 30th Apr 2024
measure: Number of subjects in both cohorts who were treated with antibiotics/antivirals during respiratory tract infections of the second observation period (whole population, with risk factor, without risk factor)
timeFrame: from 22nd Dec 2024 to 30th Apr 2025
measure: Description of severity of respiratory tract infections during the whole observation period in both cohorts (whole population, with risk factor, without risk factor)
timeFrame: from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Dr F Pugliese
city: Cagliari
country: Italy
facility: Università degli Studi di Cagliari
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Fisciano
country: Italy
facility: Università degli studi di salerno
city: Napoli
country: Italy
facility: Dr M D'Onofrio
city: Padova
country: Italy
facility: Azienda Ospedale Università Padova
city: Padova
country: Italy
facility: Azienda Ospedale-Università Padova
city: Parma
country: Italy
facility: Dr F Gatti
city: Popoli
country: Italy
facility: A.S.L. di Pescara - Abruzzo
city: Roma
country: Italy
facility: Dr F R Amorosi
city: Roma
country: Italy
facility: Dr G Marrocco
city: Roma
country: Italy
facility: Dr S Narzisi
city: Roma
country: Italy
facility: Dr A Galli
city: Roma
country: Italy
facility: Dr C Governale
city: Roma
country: Italy
facility: Dr E Meco
city: Roma
country: Italy
facility: Dr A M Pistuddi
city: Roma
country: Italy
facility: Dr R Chini
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore
city: Roma
country: Italy
facility: Dr G Biondi
city: Salerno
country: Italy
facility: Dr C Nicoletta
city: Torino
country: Italy
facility: Azienda Ospedaliera Mauriziano di Torino
city: Varese
country: Italy
facility: ASST dei Sette Laghi
city: Vibo Valentia
country: Italy
facility: ASP Vibo Valentia
Study officials:
affiliation: Institute of Translational Pharmacology, Italian National Research Council (IFT-CNR)
name: Sergio Bonini, Professor
role: PRINCIPAL_INVESTIGATOR
References: