Viral Pulmonary InfectionsVIRAGENCT07539103
VIRal Pulmonary Infections in Older AGE
An observational study of Viral Pulmonary Infections, run by Gérond'if at 20 sites in France.
Trial summary
Severe acute respiratory infections (SARIs) represent one of the leading causes of hospitalization and mortality worldwide. These infections are associated with substantial in-hospital mortality and often constitute a turning point in the medium-term prognosis of older patients and those with comorbid conditions. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Viral Pulmonary Infections
- How many people
- 5,900 participants
- Where
- 20 sitesFrance
- Study dates
- 22 Oct 2026to 21 Jan 2029
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized older patients (≥60 years old) tested for PCR as part of standard of care (SoC). Subjects meeting the eligibility criteria will be invited to participate in the study.
Who may be able to join
- Hospitalized subjects aged ≥ 60 years
- A respiratory sample collected and tested by polymerase chain reaction (PCR) during hospitalisation as part of standard of care
- Note: Reasons for PCR:
- Patients with Severe acute respiratory infection (SARI)
- Patients with symptoms other than SARI
- Systematic PCR testing (in the context of clusters or during the winter season) * Recent onset of at least one general symptom and at least one functional or physical respiratory sign
Show all 10Show fewer
- General symptoms: fever (which may be absent in older patients), chills, sweating, headache, malaise, myalgia, arthralgia, fatigue, decline in general condition (asthenia, weight loss, anorexia, confusion, or dizziness), digestive disturbances.
- Respiratory signs: sore throat, rhinorrhoea (common cold), cough, wheezing, dyspnoea, chest pain, or recent auscultatory abnormalities (diffuse or focal).
- Subjects willing to participate, with a non-opposition form completed and signed by the qualified and trained healthcare professional responsible for providing the participant information
- Subject affiliated to a health insurance system
Who cannot join
- Subjects refusing to participate
- Subjects admitted to palliative care unit.
- Subjects under guardianship
- Any condition that, in the opinion of the investigator, may interfere with the aim of the study or wellbeing of the patient
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites, 20 recruiting
- Not yet recruiting
CHU Amiens Picardie
Amiens, 80054
Jean-Philippe LANOIX, 03.22.66.88.13, lanoix.jean-philippe@chu-amiens.fr
- Recruiting
Hôpital Avicenne APHP
Bobigny, Île-de-France Region, 93000
Frédéric PAMOUKDJIAN, 01 48 95 70 34, frederic.pamoukdjian@aphp.fr
- Not yet recruiting
Hôpital Ambroise Paré-APHP
Boulogne-Billancourt, Île-de-France Region, 92100
Marion PEPIN, 01 49 09 47 50, marion.pepin@aphp.fr
Tristan CUDENNEC, 01 49 09 48 55, tristan.cudenec@aphp.fr
- Not yet recruiting
Hôpital Henri Mondor APHP
Créteil, Île-de-France Region, 94010
Marie LAURENT, 01 49 81 33 63, marie.laurent@aphp.fr
- Not yet recruiting
Hôpital Corentin Celton APHP, Gérontologie 1
Issy-les-Moulineaux, Île-de-France Region, 92130
Anthony MEZIERE, 01 58 00 41 31, anthony.meziere@gerondif.org
- Recruiting
Hôpital Corentin Celton APHP, Gérontologie 2
Issy-les-Moulineaux, Île-de-France Region, 92130
Cécile LEGENDRE, 01 58 00 41 31, cecile.legendre@aphp.fr
- Not yet recruiting
Hôpital Charles Foix APHP
Ivry-sur-Seine, Île-de-France Region, 94200
Joel BELMIN, 01 49 59 45 65, j.belmin@aphp.fr
- Recruiting
Centre Hospitalier Départemental Vendée_La Roche sur Yon
La Roche-sur-Yon, 85925
Thomas GUIMARD, 02 51 44 63 85, thomas.guimard@ght85.fr
- Not yet recruiting
CH de Versailles
Le Chesnay, Île-de-France Region, 78157
Delphine ROMAIN, 01 39 63 93 22, dromain@ght78sud.fr
- Recruiting
Hôpital Emile Roux APHP
Limeil-Brévannes, Île-de-France Region, 94450
Amaury BROUSSIER, 01 45 95 80 80, amaury.broussier@aphp.fr
- Not yet recruiting
CHU Nimes
Nîmes, 30029
Paul LOUBET, 04 66 68 41 49, paul.loubet@chu-nimes.fr
- Not yet recruiting
Hôpital St Antoine
Paris, 75012
Karine LACOMBE, 01 49 28 24 38, karine.lacombe@aphp.fr
- Recruiting
Hôpital Broca - APHP
Paris
Olivier HANON, MD PHD, 01 44 08 33 81, olivier.hanon@aphp.fr
- Not yet recruiting
HEGP
Paris, Île-de-France Region, 75015
Elena PAILLAUD, 01 56 09 33 10, elena.paillaud@aphp.fr
- Not yet recruiting
Hôpital Bretonneau APHP
Paris, Île-de-France Region, 75016
Olivier DRUNAT, 01 53 11 17 10, olivier.drunat@aphp.fr
- Not yet recruiting
Hôpital Sainte Périne
Paris, Île-de-France Region, 75016
Laurent LECHOWSKI, 01 44 96 32 66, laurent.lechowski@aphp.fr
- Not yet recruiting
Hôpital Lariboisière - APHP
Paris, Île-de-France Region, 75475
Matthieu LILAMAND, 01 85 73 73 28, matthieu.lilamand@aphp.fr
- Not yet recruiting
Hôpital Bichat-APHP
Paris, Île-de-France Region, 75877
Agathe RAYNAUD-SIMON, 01 40 25 73 69, agathe.raynaud-simon@aphp.fr
- Not yet recruiting
CHU Bordeaux
Pessac, Bordeaux, 33604
Claire ROUBAUD-BAUDRON, 05 57 65 65 67, claire.roubaud@chu-bordeaux.fr
- Not yet recruiting
Hôpital Paul Brousse APHP
Villejuif, Île-de-France Region, 94800
Emmanuelle DURON, 01 45 59 39 57, emmanuelle.duron@aphp.fr
About this study
Severe acute respiratory infections (SARIs) represent one of the leading causes of hospitalization and mortality worldwide. These infections are associated with substantial in-hospital mortality and often constitute a turning point in the medium-term prognosis of older patients and those with comorbid conditions.
SARIs are most frequently of viral origin, involving well-known pathogens such as Orthomyxoviridae (influenza A and B viruses), Pneumoviridae [(respiratory syncytial virus (RSV), human metapneumovirus (hMPV)], Paramyxoviridae [parainfluenza viruses (PIV)], adenoviruses, or rhinoviruses, as well as emerging viruses such as pandemic influenza strains and the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of the COVID-19 pandemic.
Read more
Age-related immune decline (immunosenescence) increases the risk of severe forms and related respiratory or cardiovascular complications. However, the prevalence and burden of the different viral etiologies of Severe acute respiratory infections (SARIs) in older adults remain limited and insufficiently characterized.
The primary objective is to determine the proportion of viral respiratory infections attributable to polymerase chain reaction (PCR)-confirmed pathogen agents among hospitalized older subjects (≥60 years old).
Read the detailed description
This is an observational, prospective, multicentre study in hospitalized older patients (≥60 years old) who have undergone viral respiratory sampling (RT-PCR or multiplex RT-PCR).
Subjects will be recruited over a period of 24 months at approximately 20 centres. Each subject will participate in the study for 3 months (Screening/inclusion visit and 3-month follow-up phone calls post hospital discharge). A respiratory sample (nasopharyngeal or nasal swab, oropharyngeal swab, aspirate, or bronchoalveolar lavage fluid) will be collected as part of standard of care and analysed by the local virology laboratory for the detection of respiratory virus(es) responsible for the infection, using validated Reverse transcription polymerase chain reaction (RT-PCR) or multiplex RT-PCR assays.
- Conditions
- Viral Pulmonary Infections
- Keywords
- PCR, viral respiratory infections, viral respiratory pathogen, polymerase chain reaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of RT-PCR-confirmed positive cases for viral pathogen agents of interest among hospitalized older subjects (≥60 years old)
Measured: At baseline
Secondary outcomes (9)
Number of RT-PCR-confirmed positive cases for each viral pathogen agent of interest among hospitalized older subjects
Measured: From baseline to 3-month follow-up
Number of RT-PCR-confirmed positive cases for each viral pathogen of interest among hospitalized older subjects according to the vaccination status
Measured: From baseline to 3-month follow-up
Number of RT-PCR -confirmed positive cases for each viral respiratory pathogen of interest among hospitalized older subjects according to the indication of PCR
Measured: From baseline to 3-month follow-up
Comparison of the prevalence of viral respiratory pathogen of interest among hospitalized older subjects by age groups
Measured: From baseline to 3-month follow-up
Hospital burden of acute respiratory infections
including:
- Mortality (in-hospital and at 3-month follow-up)
- Length of hospital stay, admissions to intensive or critical care units, and use of ventilatory support (mechanical ventilation)
- In-hospital geriatric syndromes: • Delirium: CAM (Confusion Assessment Method) score • Malnutrition: weight loss, serum albumin • Sarcopenia: one-leg stance test (unipedal stance test), Timed Up and Go (TUG) test (at admission and discharge) • Cognitive impairment: MMSE (Mini-Mental State Examination) score • Pressure ulcers
- Extra-respiratory complications (in-hospital and during follow-up): • Cardiovascular complications (acute coronary syndrome, heart failure, atrial fibrillation, stroke) • Non-cardiovascular complications (digestive disorders, non-respiratory infections, acute kidney injury, metabolic disorders, etc.)
- Functional autonomy: 15 days before hospitalization, at discharge, and at 3 months using ADL (Activities of Daily Living) and IADL (Instrumental Activities of Daily Living) sc
Measured: From baseline to 3 month follow up
Hospital burden of acute viral respiratory infections according to the indication of PCR
Measured: From baseline to 3 month follow up
Prevalence of co-infections with the viral respiratory pathogens of interest among hospitalized older subjects.
Measured: From baseline to 3-month follow-up
Patient characterization by age, sex, associated protective and risk factors, overall and by viral pathogen.
Measured: At baseline
Epidemiological trends and seasonality of respiratory viruses during the study period.
Measured: From baseline to 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start22 Oct 2026
- Primary completion21 Jan 2029 (estimated)
- Study completion21 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Pulmonary InfectionsStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 5,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Hanon, MD PhD, Study chair, Geriatric Department, Broca hospitalLAUNAY Odile, MD PhD, Study chair, CIC de Vaccinologie Cochin Pasteur (CIC 1417)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539103
- Sponsor's protocol ID
- 2025-A01962-47
- Acronym
- VIRAGE
- Status last verified
- Nov 2026
- First submitted
- 1 Apr 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIRal Pulmonary Infections in Older AGE
- ClinicalTrials.gov ID
- NCT07539103
- Acronym / sponsor ID
- VIRAGE / 2025-A01962-47
- Conditions
- Viral Pulmonary Infections
- Keywords
- PCR, viral respiratory infections, viral respiratory pathogen, polymerase chain reaction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,900 participants (estimated)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 22 Oct 2026 (actual)
- Primary completion
- 21 Jan 2029 (estimated)
- Study completion
- 21 Jan 2029 (estimated)
- First posted
- 20 Apr 2026 (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.
Severe acute respiratory infections (SARIs) represent one of the leading causes of hospitalization and mortality worldwide. These infections are associated with substantial in-hospital mortality and often constitute a turning point in the medium-term prognosis of older patients and those with comorbid conditions.
SARIs are most frequently of viral origin, involving well-known pathogens such as Orthomyxoviridae (influenza A and B viruses), Pneumoviridae [(respiratory syncytial virus (RSV), human metapneumovirus (hMPV)], Paramyxoviridae [parainfluenza viruses (PIV)], adenoviruses, or rhinoviruses, as well as emerging viruses such as pandemic influenza strains and the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of the COVID-19 pandemic.
Age-related immune decline (immunosenescence) increases the risk of severe forms and related respiratory or cardiovascular complications. However, the prevalence and burden of the different viral etiologies of Severe acute respiratory infections (SARIs) in older adults remain limited and insufficiently characterized.
The primary objective is to determine the proportion of viral respiratory infections attributable to polymerase chain reaction (PCR)-confirmed pathogen agents among hospitalized older subjects (≥60 years old).
Detailed description
This is an observational, prospective, multicentre study in hospitalized older patients (≥60 years old) who have undergone viral respiratory sampling (RT-PCR or multiplex RT-PCR).
Subjects will be recruited over a period of 24 months at approximately 20 centres. Each subject will participate in the study for 3 months (Screening/inclusion visit and 3-month follow-up phone calls post hospital discharge). A respiratory sample (nasopharyngeal or nasal swab, oropharyngeal swab, aspirate, or bronchoalveolar lavage fluid) will be collected as part of standard of care and analysed by the local virology laboratory for the detection of respiratory virus(es) responsible for the infection, using validated Reverse transcription polymerase chain reaction (RT-PCR) or multiplex RT-PCR assays.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized older patients (≥60 years old) tested for PCR as part of standard of care (SoC). Subjects meeting the eligibility criteria will be invited to participate in the study.
Key inclusion criteria (10 listed)
- Hospitalized subjects aged ≥ 60 years
- A respiratory sample collected and tested by polymerase chain reaction (PCR) during hospitalisation as part of standard of care
- Patients with Severe acute respiratory infection (SARI)
- Patients with symptoms other than SARI
- Systematic PCR testing (in the context of clusters or during the winter season) * Recent onset of at least one general symptom and at least one functional or physical respiratory sign
Key exclusion criteria (4 listed)
- Subjects refusing to participate
- Subjects admitted to palliative care unit.
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
Number of RT-PCR-confirmed positive cases for viral pathogen agents of interest among hospitalized older subjects (≥60 years old)
Time frame: At baseline
9 secondary outcomes
Number of RT-PCR-confirmed positive cases for each viral pathogen agent of interest among hospitalized older subjects
Time frame: From baseline to 3-month follow-up
Number of RT-PCR-confirmed positive cases for each viral pathogen of interest among hospitalized older subjects according to the vaccination status
Time frame: From baseline to 3-month follow-up
Number of RT-PCR -confirmed positive cases for each viral respiratory pathogen of interest among hospitalized older subjects according to the indication of PCR
Time frame: From baseline to 3-month follow-up
Comparison of the prevalence of viral respiratory pathogen of interest among hospitalized older subjects by age groups
Time frame: From baseline to 3-month follow-up
Hospital burden of acute respiratory infections
Time frame: From baseline to 3 month follow up
Hospital burden of acute viral respiratory infections according to the indication of PCR
Time frame: From baseline to 3 month follow up
Prevalence of co-infections with the viral respiratory pathogens of interest among hospitalized older subjects.
Time frame: From baseline to 3-month follow-up
Patient characterization by age, sex, associated protective and risk factors, overall and by viral pathogen.
Time frame: At baseline
Epidemiological trends and seasonality of respiratory viruses during the study period.
Time frame: From baseline to 3 month follow up
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 6 Nov 2026.
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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.
Olivier Hanon, MD PhD study chair
Geriatric Department, Broca hospital
LAUNAY Odile, MD PhD study chair
CIC de Vaccinologie Cochin Pasteur (CIC 1417)
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Pulmonary Infections, run by Gérond'if at 20 sites in France.
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 10 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. 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 Isabelle Dufour (+33 (0) 185781011, isabelle.dufour@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of RT-PCR-confirmed positive cases for viral pathogen agents of interest among hospitalized older subjects (≥60 years old) (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.