NCT Number: NCT07539103
VIRal Pulmonary Infections in Older AGE
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).
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Conditions
Age range
60 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
CHU Bordeaux, Pessac, Bordeaux, France
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
- 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
- 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
Treatment and study plan
Primary outcomes
-
Number of RT-PCR-confirmed positive cases for viral pathogen agents of interest among hospitalized older subjects (≥60 years old)
Time frame: At baseline
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
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
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Isabelle Dufour
CONTACT
Prisca Lucas, PhD MPH
CONTACT
Sponsors and collaborators
Lead sponsor
Gérond'if
Other
Registry information
Acronym: VIRAGE
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Apr 20, 2026
- Registry last updated
- Apr 20, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.