Study of Viral Respiratory Infections

NCT ID: NCT06764381

Last Updated: 2025-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-03

Study Completion Date

2026-02-03

Brief Summary

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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

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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.

Conditions

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Respiratory Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Adult patients

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

No interventions assigned to this group

Pediatric patients

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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giulio Virgili, MD

Role: STUDY_CHAIR

Azienda Usl di Bologna

Maddalena Giannella, MD

Role: STUDY_CHAIR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Ilaria Corsini, MD

Role: STUDY_CHAIR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status

Countries

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Italy

Central Contacts

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Liliana Gabrielli, MD

Role: CONTACT

+390512414645

Giulia Piccirilli, PhD

Role: CONTACT

Facility Contacts

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Liliana Gabrielli, MD

Role: primary

+390512144645

References

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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.

Reference Type BACKGROUND
PMID: 36581046 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39554593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37242316 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34574450 (View on PubMed)

Other Identifiers

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RESP-VIR

Identifier Type: -

Identifier Source: org_study_id

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