Clinical trial NCT06764381: Study of Viral Respiratory Infections
Official 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Respiratory Infections
Keywords: infection
virus
respiratory
RSV
SARS-CoV-2
FLUA
FLUB
AdV
MPV
PIV
Adenovirus
Metapneumovirus
Severe acute respiratory syndrome
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and pediatric patients of the Sant'Orsola Hospital

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identify potential changes in the circulation of major respiratory viruses (FLUA, FLUB, VRS, AdV, PIV, MPV, RV) during the period 2018-2023.
timeFrame: From 2018 to 2023
Secondary outcomes:
measure: 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
timeFrame: From 2022 to 2023
Other outcomes:
measure: 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
timeFrame: From 2022 to 2023
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: Azienda Usl di Bologna
name: Giulio Virgili, MD
role: STUDY_CHAIR
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Maddalena Giannella, MD
role: STUDY_CHAIR
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Ilaria Corsini, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.