Survey of Incidence of Respiratory Tract Infections (SIRTI)

August 5, 2025 updated by: Lallemand Pharma AG

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1736

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Bari, Italy, 70121
        • Dr F Pugliese
      • Cagliari, Italy, 09124
        • Università degli Studi di Cagliari
      • Firenze, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi
      • Fisciano, Italy, 84084
        • Università degli studi di salerno
      • Napoli, Italy, 80137
        • Dr M D'Onofrio
      • Padova, Italy, 35128
        • Azienda Ospedale Universita Padova
      • Padova, Italy, 35128
        • Azienda Ospedale-Universita Padova
      • Parma, Italy, 43121
        • Dr F Gatti
      • Popoli, Italy, 65026
        • A.S.L. di Pescara - Abruzzo
      • Roma, Italy, 00168
        • Universita Cattolica del Sacro Cuore
      • Roma, Italy, 00010
        • Dr F R Amorosi
      • Roma, Italy, 00012
        • Dr G Marrocco
      • Roma, Italy, 00019
        • Dr S Narzisi
      • Roma, Italy, 00038
        • Dr A Galli
      • Roma, Italy, 00060
        • Dr C Governale
      • Roma, Italy, 00065
        • Dr E Meco
      • Roma, Italy, 00156
        • Dr A M Pistuddi
      • Roma, Italy, 00168
        • Dr R Chini
      • Roma, Italy, 00169
        • Dr G Biondi
      • Salerno, Italy, 84121
        • Dr C Nicoletta
      • Torino, Italy, 10128
        • Azienda Ospedaliera Mauriziano di Torino
      • Varese, Italy, 21100
        • ASST dei Sette Laghi
      • Vibo Valentia, Italy, 89900
        • ASP Vibo Valentia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

Male or female aged from at least 18 years -

Exclusion Criteria:

Minor subjects-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Other: No intervention
no difference: both cohorts are followed in the same way

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of respiratory tract infections during the whole observation period (whole population, with risk factor, without risk factor)
Time Frame: From 22nd Dec 2023 to 30th Apr2024 and from 22nd Dec 2024 to 30th Apr 2025
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
Time Frame: from 22nd Dec 2023 to 30th Apr 2024
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)
Time Frame: from 22nd Dec 2024 to 30th Apr 2025
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
Time Frame: From 22nd Dec 2024 to 30th Apr 2025
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)
Time Frame: from 22nd Dec 2023 to 30th Apr 2024
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)
Time Frame: from 22nd Dec 2024 to 30th Apr 2025
from 22nd Dec 2024 to 30th Apr 2025
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)
Time Frame: from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
from 22nd Dec 2023 to 30th Apr 2024 and 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 RTI positive (whole population, with risk factor, without risk factor
Time Frame: from 22nd Dec 2023 to 30th Apr 2024
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 RTI positive (whole population, with risk factor, without risk factor)
Time Frame: from 22nd Dec 2024 to 30th Apr 2025
from 22nd Dec 2024 to 30th Apr 2025
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)
Time Frame: from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
Time to first respiratory infection during the first observation period (whole population, with risk factor, without risk factor) for subjects of the Cohort Incidence
Time Frame: from 22nd Dec 2023 to 30th Apr 2024
from 22nd Dec 2023 to 30th Apr 2024
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
Time Frame: from 22nd Dec 2024 to 30th Apr 2025
from 22nd Dec 2024 to 30th Apr 2025
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
Time Frame: 023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025 from 22nd Dec 2
023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025 from 22nd Dec 2
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)
Time Frame: from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
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)
Time Frame: from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
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)
Time Frame: from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
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)
Time Frame: from 22nd Dec 2023 to 30th Apr 2024
from 22nd Dec 2023 to 30th Apr 2024
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)
Time Frame: from 22nd Dec 2024 to 30th Apr 2025
from 22nd Dec 2024 to 30th Apr 2025
Description of severity of respiratory tract infections during the whole observation period in both cohorts (whole population, with risk factor, without risk factor)
Time Frame: from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025
from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lallemand Pharma AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istituto di Farmacologia Traslazionale - National Research Council (IFT-CNR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sergio Bonini, Professor, Institute of Translational Pharmacology, Italian National Research Council (IFT-CNR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 17, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023/09/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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