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.
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
- Conditions the study is for
- Infectious Respiratory Diseases, Hospitalized Patients, Adult Patients
- 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
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 group | Role | What 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.
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.
- First posted2 Jul 2025
- Study start7 Jan 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious Respiratory DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence for Respiratory Infections SEverity Prediction
- ClinicalTrials.gov ID
- NCT07047768
- Acronym / sponsor ID
- AIRISE / 69HCL24_1114_1
- Keywords
- Prediction, Artificial Intelligence, Infectious respiratory diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 52,000 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 2 Jul 2025 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute lower respiratory tract infections (ALRTI) | – | Other: No intervention : data-based studyAdult 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 qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients under 18 years of age at the time of care;
- Patient refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention : data-based studyNo intervention : data-based study | Other | Patients with acute lower respiratory tract infections (ALRTI) |
Primary outcome
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.
The primary outcome was admission to intensive care unit during the study period
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 2 Jul 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.