Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649032
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Survey of Incidence of Respiratory Tract Infections
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIRTI
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 approx1000 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
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 approx1000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None