Study of Viral Respiratory Infections

Not yet recruiting

• Conditions: Respiratory Infections

• Registration Number: NCT06764381
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

Acute viral respiratory infections are a major public health problem, as they cause mortality especially in pediatric patients, over 65 and those with co-morbidities. The most frequently responsible viruses are: Influenza A and B, Respiratory Syncytial Virus, Adenovirus, Parainfluenza Virus, Metapneumovirus, Rhinovirus and SARS-CoV-2. By comparing clinical data and laboratory diagnosis among all categories of patients at greatest risk, it is possible to define the symptoms associated with the pathogen and establish which etiological agents could be able to cause clinical pictures characteristics of a given type of patient. The study will also provide information on the potential role that simultaneously detected pathogens may play in determining the severity of the clinical picture. In addition, the results will allow to deepen the changes in seasonality and spread of different respiratory viruses associated with the COVID-19 pandemic.

Detailed Description

The aim of the study is:

1. Calculate the percentage of positive cases during 2018-2023.

2. Association between the viral pathogens detected individually or in packaging in respiratory material and: typology of symptomatology/clinical outcome; typology of clinical signs detectable with objective/instrumental examinations; degree of severity of clinical manifestation.

3. Reduction in the prescription of instrumental investigations (RX/ecoaddome) and reduction in the prescription of empirical antibiotic therapy with amoxicillin or amoxicillin and clavulanic acid in pediatric patients.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-08
• Study Start: 2025-02-03
• Primary Completion: 2025-03-03
• Study Completion: 2026-02-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• Adult and pediatric patients, of any age, with clinical diagnosis of acute respiratory infections and with request for search of the main respiratory viruses (FLUA, FLUB, VRS, AdV, PIV, MPV, RV and SARS-CoV-2)
• Obtaining informed consent where possible.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify potential changes in the circulation of major respiratory viruses (FLUA, FLUB, VRS, AdV, PIV, MPV, RV) during the period 2018-2023.	From 2018 to 2023	Requests for the detection of respiratory viruses (FLUA, FLUB, VRS, AdV, PIV, MPV, RV and SARS-CoV-2) will be selected for virological diagnosis received from 2018.09.01 to 2023.08.31 and related to adult and pediatric patients at Hospitals and sampling points in the Metropolitan area of Bologna.The percentage of positive cases (positive number/ total requested) will be calculated for weeks during the study period. The comparison of the positivity found in different epidemic seasons will be performed: first (epidemic season 2018-2019), during (epidemic seasons 2019-2020, 2020-2021, 2021-2022) and after the COVID-19 pandemic (epidemic season 2022-2023) for each pathogen studied. We expect to observe differences in the frequency of each pathogen in the different weeks of the epidemic seasons 2018-2023.

Secondary Outcome Measures

Name	Time	Method
Define the potential role that each pathogen may have in the onset and outcome of certain clinical conditions (symptoms and clinical signs) in adult and pediatric patients	From 2022 to 2023	The applications for virological diagnosis (FLUA, FLUB, VRS, AdV, PIV, MPV, RV and SARS-CoV-2) received during the last epidemic season (2022-2023) will be selected and relate to adult and pediatric patients of the Policlinico di S. Orsola. For each of the selected cases, data on the patient's clinical characteristics and laboratory tests will be retrieved. These data will be related to the positive findings for the viruses listed above, by means of virological diagnosis on respiratory material. In addition, the results obtained in the different categories of patients (pediatric, adult, fragile for comorbidities) will be used for the association between viral pathogens detected individually or in packaging in respiratory material and: type of symptoms/clinical outcome; type of clinical signs detectable with objective/instrumental examinations; degree of severity of the clinical manifestation.

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy