NCT07539103

Brief 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. 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,900

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

20 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

April 1, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

PCRviral respiratory infectionsviral respiratory pathogenpolymerase chain reaction

Outcome Measures

Primary Outcomes (1)

  • Number of RT-PCR-confirmed positive cases for viral pathogen agents of interest among hospitalized older subjects (≥60 years old)

    At baseline

Secondary Outcomes (9)

  • Number of RT-PCR-confirmed positive cases for each viral pathogen agent of interest among hospitalized older subjects

    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

    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

    From baseline to 3-month follow-up

  • Comparison of the prevalence of viral respiratory pathogen of interest among hospitalized older subjects by age groups

    From baseline to 3-month follow-up

  • Hospital burden of acute respiratory infections

    From baseline to 3 month follow up

  • +4 more secondary outcomes

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

CHU Bordeaux

Pessac, Bordeaux, 33604, France

Location

CHU Amiens Picardie

Amiens, 80054, France

Location

Centre Hospitalier Départemental Vendée_La Roche sur Yon

La Roche-sur-Yon, 85925, France

Location

CHU Nimes

Nîmes, 30029, France

Location

Hôpital St Antoine

Paris, 75012, France

Location

Hôpital Broca - APHP

Paris, France

Location

Hôpital Avicenne APHP

Bobigny, Île-de-France Region, 93000, France

Location

Hôpital Ambroise Paré-APHP

Boulogne-Billancourt, Île-de-France Region, 92100, France

Location

Hôpital Henri Mondor APHP

Créteil, Île-de-France Region, 94010, France

Location

Hôpital Corentin Celton APHP, Gérontologie 1

Issy-les-Moulineaux, Île-de-France Region, 92130, France

Location

Hôpital Corentin Celton APHP, Gérontologie 2

Issy-les-Moulineaux, Île-de-France Region, 92130, France

Location

Hôpital Charles Foix APHP

Ivry-sur-Seine, Île-de-France Region, 94200, France

Location

CH de Versailles

Le Chesnay, Île-de-France Region, 78157, France

Location

Hôpital Emile Roux APHP

Limeil-Brévannes, Île-de-France Region, 94450, France

Location

HEGP

Paris, Île-de-France Region, 75015, France

Location

Hôpital Bretonneau APHP

Paris, Île-de-France Region, 75016, France

Location

Hôpital Sainte Périne

Paris, Île-de-France Region, 75016, France

Location

Hôpital Lariboisière - APHP

Paris, Île-de-France Region, 75475, France

Location

Hôpital Bichat-APHP

Paris, Île-de-France Region, 75877, France

Location

Hôpital Paul Brousse APHP

Villejuif, Île-de-France Region, 94800, France

Location

Study Officials

  • Olivier Hanon, MD PhD

    Geriatric Department, Broca hospital

    STUDY CHAIR
  • LAUNAY Odile, MD PhD

    CIC de Vaccinologie Cochin Pasteur (CIC 1417)

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 20, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

April 20, 2026

Record last verified: 2026-04

Locations