A Multicentric Epidemiological Study of the Actual Incidence of Respiratory Tract Infections in an Adult Italian Population, With or Without Underlying Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,736
- 试验地点
- 23
- 主要终点
- Incidence of respiratory tract infections during the whole observation period (whole population, with risk factor, without risk factor)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged from at least 18 years -
排除标准
- •Minor subjects-
结局指标
主要结局
Incidence of respiratory tract infections during the whole observation period (whole population, with risk factor, without risk factor)
时间窗: 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.
次要结局
- 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)(from 22nd Dec 2023 to 30th Apr 2024)
- 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)
- 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)(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(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)(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)(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(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(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(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)(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)(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)(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 second observation period (whole population, with risk factor, without risk factor)(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)(from 22nd Dec 2023 to 30th Apr 2024 and from 22nd Dec 2024 to 30th Apr 2025)