Survey of Incidence of Respiratory Tract Infections

NCT06649032 | Completed

• 1 other identifier: 2023/09/01
• Study Type: observational
• Target: 1,736
• Locations: 1 country
• Sites: 23

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.

Conditions

Healthy Adults; Not Healthy Adults

Keywords

incidence; adults; respiratory tract infections

Outcome Measures

Primary Outcomes (1)

• Incidence of respiratory tract infections during the whole observation period (whole population, with risk factor, without risk factor)

  Overall mean number of respiratory tract infections during both observation periods (whole period), mean number of respiratory tract infections for subjects with or without risk factors during the whole period.

  From 22nd Dec 2023 to 30th Apr2024 and from 22nd Dec 2024 to 30th Apr 2025

Secondary Outcomes (18)

• 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)

  from 22nd Dec 2023 to 30th Apr 2024

• 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)

  from 22nd Dec 2024 to 30th Apr 2025

• Number of subjects from the Cohort RTI positive who had at least one respiratory tract infection during the second observation period

  From 22nd Dec 2024 to 30th Apr 2025

• 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)

  from 22nd Dec 2023 to 30th Apr 2024

• 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)

  from 22nd Dec 2024 to 30th Apr 2025

Study Arms (2)

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).

Other: No intervention

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.

Other: No intervention

Interventions

No intervention OTHER

no difference: both cohorts are followed in the same way

Cohort Incidence; Cohort Respiratory Tract Infections (RTI) positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male or female aged from at least 18 years -

You may not qualify if:

• Minor subjects-

Sponsors & Collaborators

• Lallemand Pharma AG: lead
• Istituto di Farmacologia Traslazionale - National Research Council (IFT-CNR): collaborator

Study Sites (23)

Dr F Pugliese

Bari, 70121, Italy

Location

Università degli Studi di Cagliari

Cagliari, 09124, Italy

Location

Università degli studi di salerno

Fisciano, 84084, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

Location

Dr M D'Onofrio

Napoli, 80137, Italy

Location

Azienda Ospedale Università Padova

Padua, 35128, Italy

Location

Azienda Ospedale-Università Padova

Padua, 35128, Italy

Location

Dr F Gatti

Parma, 43121, Italy

Location

A.S.L. di Pescara - Abruzzo

Popoli, 65026, Italy

Location

Dr F R Amorosi

Roma, 00010, Italy

Location

Dr G Marrocco

Roma, 00012, Italy

Location

Dr S Narzisi

Roma, 00019, Italy

Location

Dr A Galli

Roma, 00038, Italy

Location

Dr C Governale

Roma, 00060, Italy

Location

Dr E Meco

Roma, 00065, Italy

Location

Dr A M Pistuddi

Roma, 00156, Italy

Location

Dr R Chini

Roma, 00168, Italy

Location

Università Cattolica del Sacro Cuore

Roma, 00168, Italy

Location

Dr G Biondi

Roma, 00169, Italy

Location

Dr C Nicoletta

Salerno, 84121, Italy

Location

Azienda Ospedaliera Mauriziano di Torino

Torino, 10128, Italy

Location

ASST dei Sette Laghi

Varese, 21100, Italy

Location

ASP Vibo Valentia

Vibo Valentia, 89900, Italy

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Sergio Bonini, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: November 7, 2023
• Primary Completion: May 31, 2025
• Study Completion: July 17, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

IT (23)