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Infectious Respiratory DiseasesAIRISENCT07047768

Artificial Intelligence for Respiratory Infections SEverity Prediction

An observational study of Infectious Respiratory Diseases and Hospitalized Patients, run by Hospices Civils de Lyon at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Health Data Warehouses (HDWs) are a major resource for the development of artificial intelligence (AI) applied to predictive and personalized medicine. We propose a project leveraging the HDW of the Hospices Civils de Lyon (HCL) to study acute lower respiratory tract infections (ALRTIs), a major public health issue… Read more about this study

Who is it for?
Ages 18 years and older
How many people
52,000 participants
Where
1 siteFrance
Study dates
7 Jan 2025to 30 Apr 2027
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients (aged ≥ 18 years) admitted to the emergency department and/or hospitalized in one of the Hospices Civils de Lyon departments for a respiratory infection between January 1, 2017, and April 30, 2024.

Who may be able to join

  • Adult patients (aged ≥ 18 years);
  • With a visit to the emergency department and/or hospitalization in one of the Hospices Civils de Lyon departments;
  • With a diagnosis of lower respiratory tract infection (ICD-10 code);
  • Between January 1, 2017, and April 30, 2024;
  • Who did not object to participating in the study.

Who cannot join

  • Patients under 18 years of age at the time of care;
  • Patient refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hygiène, épidémiologie, infectiovigilance et prévention GHN, Hôpital Croix-Rousse

    Lyon

Other trials in France

About this study

Health Data Warehouses (HDWs) are a major resource for the development of artificial intelligence (AI) applied to predictive and personalized medicine. We propose a project leveraging the HDW of the Hospices Civils de Lyon (HCL) to study acute lower respiratory tract infections (ALRTIs), a major public health issue due to their impact on morbidity, mortality, and healthcare costs. The COVID-19 pandemic has further highlighted their burden and complexity.

ALRTIs can be caused by viral agents (e.g., influenza, RSV, SARS-CoV-2) or bacterial pathogens (e.g., pneumococcus, mycoplasma, legionella), and may be acquired in the community or during hospitalization. Given their frequency and potential severity, early identification of patients at risk of clinical deterioration is crucial, especially those likely to require intensive care.

Read more

The recent deployment of the HCL HDW now allows for the structured extraction, linkage, and storage of administrative, clinical, biological, and pharmaceutical data. This system supports the reconstruction of each patient's care trajectory and clinical history, offering new opportunities for advanced modeling.

In recent years, several predictive tools have been developed to estimate the severity or prognosis of respiratory infections, including PSI/FINE, qSOFA, CURB-65, the EPIC sepsis model, and early warning systems (EWS). The COVID-19 crisis spurred the creation of new scores and models to predict clinical outcomes or mortality, as well as online tools and apps for clinicians. However, many of these tools rely on limited datasets (often single-center or small cohorts), static variables (e.g., comorbidities), and do not consider the temporal dynamics of patient data.

Some research teams have explored the use of multicenter data and machine learning (e.g., MLHO-Machine Learning to predict Health Outcomes), notably to model COVID-19 outcomes. Nonetheless, most models lack integration of longitudinal clinical and biological data, and few are generalizable to all respiratory infections. Additionally, existing tools rarely account for real-time contextual variables such as current levels of population immunity or vaccine availability.

Our project aims to develop a dynamic AI-based detection algorithm to predict the risk of ICU admission in patients with ALRTIs. The model will be trained on retrospective HDW data from the HCL, including the evolution of vital signs, laboratory values, treatments, and demographic factors. By capturing temporal trends and clinical trajectories, our algorithm will go beyond static scoring systems and offer real-time risk stratification.

Ultimately, this algorithm could be embedded in hospital information systems as a clinical decision support tool. By generating alerts for early signs of deterioration, it would enable more timely interventions, resource optimization, and improved patient outcomes.

This approach differs from existing models in two fundamental ways. First, it covers a broad patient population with viral and bacterial pneumonia of both community and hospital origin. Second, it explicitly incorporates the longitudinal dimension of health data, allowing the model to learn from dynamic changes in patient condition. This temporal perspective is key to improving prediction accuracy and enabling early detection of deterioration.

Being tested
No intervention : data-based study
Keywords
Prediction, Artificial Intelligence, Infectious respiratory diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention : data-based studyOther

    No intervention : data-based study

Study groups in NCT07047768
Study groupRoleWhat they receive
Patients with acute lower respiratory tract infections (ALRTI)Adult patients (aged ≥ 18 years) admitted to the emergency department and/or hospitalized in one of the Hospices Civils de Lyon departments for a respiratory infection between January 1, 2017, and April 30, 2024.
Receives: Other: No intervention : data-based study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Admission to intensive care unit

    The primary outcome was admission to intensive care unit during the study period

    Measured: Adult patients (aged ≥ 18 years) admitted to the emergency department and/or hospitalized in one of the Hospices Civils de Lyon departments for a respiratory infection between January 1, 2017, and April 30, 2024.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2025
  2. Study start7 Jan 2025
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

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
52,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07047768
Sponsor's protocol ID
69HCL24_1114_1
Acronym
AIRISE
Status last verified
Jun 2025
First submitted
24 Jun 2025
Last updated
2 Jul 2025
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Infectious Respiratory Diseases and Hospitalized Patients, run by Hospices Civils de Lyon at 1 site 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 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 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Admission to intensive care unit (time frame: Adult patients (aged ≥ 18 years) admitted to the emergency department and/or hospitalized in one of the Hospices Civils de Lyon departments for a respiratory infection between January 1, 2017, and April 30, 2024.). 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 2 Jul 2025.

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