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NCT Number: NCT06764381

Study of Viral Respiratory Infections

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location contact

Giulia Piccirilli, PhD

SUB_INVESTIGATOR

Giulio Virgili, MD

SUB_INVESTIGATOR

Ilaria Corsini, MD

SUB_INVESTIGATOR

Liliana Gabrielli, MD

CONTACT

[email protected]

+390512144645

Maddalena Giannella, MD

SUB_INVESTIGATOR

About this study

The aim of the study is:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identify potential changes in the circulation of major respiratory viruses (FLUA, FLUB, VRS, AdV, PIV, MPV, RV) during the period 2018-2023.

    Time frame: 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 outcomes

  1. 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

    Time frame: 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.

Other outcomes

  1. Assess the clinical utility of performing a correct and timely virological diagnosis in terms of reducing antibiotic therapy prescription and instrumental investigations in pediatric patients

    Time frame: From 2022 to 2023

    The applications for virological diagnosis (FLUA, FLUB, VRS, AdV, PIV, MPV, RV and SARS-CoV-2) received in the last epidemic season (2022-2023) and related to pediatric patients at the Policlinico di S. Orsola will be selected. For each of the selected cases, clinical and laboratory data will be retrieved. In particular, based on the diagnostic care process provided at the departments involved in the study, for patients with clinical signs that suggested the prescription of antibiotic therapy, this therapy was still prescribed, Administered only if the virus tested for is negative. For patients with factors that exposed them to risk of severe respiratory disease (age <2 years, co-morbidity) and with clinical signs that suggested the prescription of antibiotic therapy, this therapy was given and then discontinued only if the virus tested for was not found. The aim is to reduce, in pediatric patients, the prescription of instrumental investigations (RX/ecoaddome) and reduction in the pr

Study contacts

Contact information is provided by the study sponsor or research team.

Giulia Piccirilli, PhD

CONTACT

[email protected]

Liliana Gabrielli, MD

CONTACT

[email protected]

+390512414645

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Study of Viral Respiratory Infections: Retrospective Evaluation of the Circulation of Respiratory Viruses, of Pathogenic-related Clinical Manifestations and of the Clinical Utility of Virological Diagnosis

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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