VIRal Pulmonary Infections in Older AGE (VIRAGE)

April 13, 2026 updated by: Gérond'if

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).

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

5900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens Picardie
      • La Roche-sur-Yon, France, 85925
        • Centre Hospitalier Départemental Vendée_La Roche sur Yon
        • Contact:
      • Nîmes, France, 30029
      • Paris, France, 75012
      • Paris, France
        • Hôpital Broca - APHP
        • Contact:
    • Bordeaux
    • Île-de-France Region
      • Bobigny, Île-de-France Region, France, 93000
      • Boulogne-Billancourt, Île-de-France Region, France, 92100
      • Créteil, Île-de-France Region, France, 94010
        • Hôpital Henri Mondor APHP
        • Contact:
      • Issy-les-Moulineaux, Île-de-France Region, France, 92130
      • Issy-les-Moulineaux, Île-de-France Region, France, 92130
        • Hôpital Corentin Celton APHP, Gérontologie 2
        • Contact:
      • Ivry-sur-Seine, Île-de-France Region, France, 94200
        • Hôpital Charles Foix APHP
        • Contact:
      • Le Chesnay, Île-de-France Region, France, 78157
        • CH de Versailles
        • Contact:
      • Limeil-Brévannes, Île-de-France Region, France, 94450
      • Paris, Île-de-France Region, France, 75015
      • Paris, Île-de-France Region, France, 75016
      • Paris, Île-de-France Region, France, 75016
      • Paris, Île-de-France Region, France, 75475
      • Paris, Île-de-France Region, France, 75877
      • Villejuif, Île-de-France Region, France, 94800

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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:

  1. Patients with Severe acute respiratory infection (SARI)
  2. Patients with symptoms other than SARI

  3. 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

    • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of RT-PCR-confirmed positive cases for viral pathogen agents of interest among hospitalized older subjects (≥60 years old)
Time Frame: At baseline
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
From baseline to 3-month follow-up
Hospital burden of acute respiratory infections
Time Frame: From baseline to 3 month follow up

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
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
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
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
At baseline
Epidemiological trends and seasonality of respiratory viruses during the study period.
Time Frame: From baseline to 3 month follow up
From baseline to 3 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gérond'if

Investigators

  • Study Chair: Olivier Hanon, MD PhD, Geriatric Department, Broca Hospital
  • Study Chair: LAUNAY Odile, MD PhD, CIC de Vaccinologie Cochin Pasteur (CIC 1417)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025-A01962-47

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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