Study of Viral Respiratory Infections

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Infections

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 Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Liliana Gabrielli, MD; Phone Number: +390512414645; Email: liliana.gabrielli@aosp.bo.it
• Study Contact Backup: Name: Giulia Piccirilli, PhD; Email: giulia.piccirilli@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Liliana Gabrielli, MD; Phone Number: +390512144645; Email: liliana.gabrielli@aosp.bo.it
    • Sub-Investigator: Giulia Piccirilli, PhD
    • Sub-Investigator: Giulio Virgili, MD
    • Sub-Investigator: Maddalena Giannella, MD
    • Sub-Investigator: Ilaria Corsini, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult and pediatric patients of the Sant'Orsola Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Adult patients; Adult patients with request for the detection of major respiratory viruses (FLUA, FLUB, VRS, AdV, PIV, MPV, RV and SARS-CoV-2).
Pediatric patients; Pediatric patients with request for the screening of major respiratory viruses (FLUA, FLUB, VRS, AdV, PIV, MPV, RV and SARS-CoV-2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify potential changes in the circulation of major respiratory viruses (FLUA, FLUB, VRS, AdV, PIV, MPV, RV) during the period 2018-2023.	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.	From 2018 to 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	From 2022 to 2023

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	From 2022 to 2023

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Study Chair: Giulio Virgili, MD, Azienda USL di Bologna; Study Chair: Maddalena Giannella, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna; Study Chair: Ilaria Corsini, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

General Publications

• Galli C, Pellegrinelli L, Giardina F, Ferrari G, Uceda Renteria SC, Novazzi F, Masi E, Pagani E, Piccirilli G, Mauro MV, Binda S, Corvaro B, Tiberio C, Lalle E, Maggi F, Russo C, Ranno S, Vian E, Pariani E, Baldanti F, Piralla A; AMCLI-GLIViRe working group. On the lookout for influenza viruses in Italy during the 2021-2022 season: Along came A(H3N2) viruses with a new phylogenetic makeup of their hemagglutinin. Virus Res. 2023 Jan 15;324:199033. doi: 10.1016/j.virusres.2022.199033. Epub 2022 Dec 26.
• Calabro GE, Rizzo C, Domnich A, DE Waure C, Rumi F, Bonanni P, Boccalini S, Bechini A, Panatto D, Amicizia D, Amodio E, Costantino C, Bert F, Lo Moro G, DI Pietro ML, Giuffrida S, Giordano V, Conversano M, Russo C, Spadea A, Ansaldi F, Grammatico F, Ricciardi R, Torrisi M, Porretta AD, Arzilli G, Scarpaleggia M, Bertola C, Vece M, Lupi C, Lorenzini E, Massaro E, Tocco M, Trapani G, Zarcone E, Munno L, Zace D, Petrella L, Vitale F, Ricciardi W. Health Technology Assessment del vaccino ricombinante adiuvato contro il virus respiratorio sinciziale (Arexvy(R)). J Prev Med Hyg. 2024 Jun 30;65(2 Suppl 1):E1-E159. doi: 10.15167/2421-4248/jpmh2024.65.2s1. eCollection 2024 Sep. No abstract available. Italian.
• Piccirilli G, Rocca A, Borgatti EC, Gabrielli L, Zama D, Pierantoni L, Leone M, Totaro C, Pavoni M, Lazzarotto T, Lanari M. Respiratory Syncytial Virus-Load Kinetics and Clinical Course of Acute Bronchiolitis in Hospitalized Infants: Interim Results and Review of the Literature. Pathogens. 2023 Apr 27;12(5):645. doi: 10.3390/pathogens12050645.
• De Francesco MA, Pollara C, Gargiulo F, Giacomelli M, Caruso A. Circulation of Respiratory Viruses in Hospitalized Adults before and during the COVID-19 Pandemic in Brescia, Italy: A Retrospective Study. Int J Environ Res Public Health. 2021 Sep 9;18(18):9525. doi: 10.3390/ijerph18189525.

Study record dates

Study Major Dates

• Study Start (Estimated): February 3, 2025
• Primary Completion (Estimated): March 3, 2025
• Study Completion (Estimated): February 3, 2026

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: SARS-CoV-2; infection; RSV; virus; respiratory; Adenovirus; PIV; MPV; Severe acute respiratory syndrome; Metapneumovirus; AdV; FLUA; FLUB
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: RESP-VIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No