Survey of Incidence of Respiratory Tract Infections

NCT ID: NCT06649032

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1736 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-07

Study Completion Date

2025-07-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Adults Not Healthy Adults

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort Incidence

This cohort will comprise subjects recruited from 1st November 2023 to 21st December 2023 and followed from 22nd December 2023 to 30th April 2024 and subjects recruited from 01st November 2024 to 21st December 2024 and followed from 22nd Dec 2024 to 30th April 2025. During the follow-up period, the subjects will be asked to report respiratory tract infections to the investigators (phone calls or study visit).

No intervention

Intervention Type OTHER

no difference: both cohorts are followed in the same way

Cohort Respiratory Tract Infections (RTI) positive

Subjects recruited from 1st November 2023 to 21st December 2023, followed from 22nd December 2023 to 30th April 2024 and who developed at least one respiratory tract infection will be also followed from 22nd December 2024 to 30th April 2025 and asked to report respiratory tract infections to the investigators.

No intervention

Intervention Type OTHER

no difference: both cohorts are followed in the same way

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

no difference: both cohorts are followed in the same way

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Male or female aged from at least 18 years -

Exclusion Criteria

Minor subjects-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istituto di Farmacologia Traslazionale - National Research Council (IFT-CNR)

UNKNOWN

Sponsor Role collaborator

Lallemand Pharma AG

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sergio Bonini, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Translational Pharmacology, Italian National Research Council (IFT-CNR)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dr F Pugliese

Bari, , Italy

Site Status

Università degli Studi di Cagliari

Cagliari, , Italy

Site Status

Università degli studi di salerno

Fisciano, , Italy

Site Status

Azienda Ospedaliero-Universitaria Careggi

Florence, , Italy

Site Status

Dr M D'Onofrio

Napoli, , Italy

Site Status

Azienda Ospedale Università Padova

Padua, , Italy

Site Status

Azienda Ospedale-Università Padova

Padua, , Italy

Site Status

Dr F Gatti

Parma, , Italy

Site Status

A.S.L. di Pescara - Abruzzo

Popoli, , Italy

Site Status

Dr F R Amorosi

Roma, , Italy

Site Status

Dr G Marrocco

Roma, , Italy

Site Status

Dr S Narzisi

Roma, , Italy

Site Status

Dr A Galli

Roma, , Italy

Site Status

Dr C Governale

Roma, , Italy

Site Status

Dr E Meco

Roma, , Italy

Site Status

Dr A M Pistuddi

Roma, , Italy

Site Status

Dr R Chini

Roma, , Italy

Site Status

Università Cattolica del Sacro Cuore

Roma, , Italy

Site Status

Dr G Biondi

Roma, , Italy

Site Status

Dr C Nicoletta

Salerno, , Italy

Site Status

Azienda Ospedaliera Mauriziano di Torino

Torino, , Italy

Site Status

ASST dei Sette Laghi

Varese, , Italy

Site Status

ASP Vibo Valentia

Vibo Valentia, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023/09/01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.