Respiratory InfectionsNCT06764381
Study of Viral Respiratory Infections
An observational study of Respiratory Infections, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Infections
- How many people
- 20,000 participants
- Where
- 1 siteItaly
- Study dates
- 3 Feb 2025to 3 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and pediatric patients of the Sant'Orsola Hospital
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Giulia Piccirilli, PhD contact
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Liliana Gabrielli, MD, +390512144645, liliana.gabrielli@aosp.bo.it
Giulia Piccirilli, PhD
About this study
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
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.
Read the detailed description
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.
- Conditions
- Respiratory Infections
- Keywords
- infection, virus, respiratory, RSV, SARS-CoV-2, FLUA, FLUB, AdV, MPV, PIV, Adenovirus, Metapneumovirus, Severe acute respiratory syndrome
- Medical subject headings
- Respiratory Tract Infections, Infections, Virus Diseases, Adenoviridae Infections, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 2018 to 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
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.
Measured: From 2022 to 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start3 Feb 2025 (estimated)
- Primary completion3 Mar 2025 (estimated)
- Study completion3 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory InfectionsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulio Virgili, MD, Study chair, Azienda Usl di BolognaMaddalena Giannella, MD, Study chair, IRCCS Azienda Ospedaliero-Universitaria di BolognaIlaria Corsini, MD, Study chair, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764381
- Sponsor's protocol ID
- RESP-VIR
- Status last verified
- Nov 2024
- First submitted
- 2 Jan 2025
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36581046Calabro 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.
PubMed 39554593Piccirilli 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.
PubMed 37242316De 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.
PubMed 34574450
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06764381
- Acronym / sponsor ID
- RESP-VIR
- Conditions
- Respiratory Infections
- Keywords
- infection, virus, respiratory, RSV, SARS-CoV-2, FLUA, FLUB, AdV
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 3 Feb 2025 (estimated)
- Primary completion
- 3 Mar 2025 (estimated)
- Study completion
- 3 Feb 2026 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric patients of the Sant'Orsola Hospital
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Background: PubMed 36581046Galli 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.
- Background: PubMed 39554593Calabro 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.
- Background: PubMed 37242316Piccirilli 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.
- Background: PubMed 34574450De 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.
- Individual participant dataSharing planned: No
Related trials for Respiratory Infections
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
VIRal Pulmonary Infections in Older AGE
Viral Pulmonary Infections
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giulia Piccirilli, PhD contact
Giulio Virgili, MD study chair
Azienda Usl di Bologna
Maddalena Giannella, MD study chair
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Ilaria Corsini, MD study chair
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Infections, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liliana Gabrielli, MD (+390512414645, liliana.gabrielli@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06764381, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.