An interventional study of Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS in Respiratory Infections, COVID-19 and Influenza Virus Infection, sponsored by Hospices Civils de Lyon. Not yet recruiting at 7 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
Among 36 studies in COVID-19 by Hospices Civils de Lyon — 5 open to participants now, 5 under way, none of them phase 3. COVID-19 · Hospices Civils de Lyon.
Among the 36 studies in COVID-19 by Hospices Civils de Lyon, this one is the 5th largest by planned enrollment of the 16 interventional ones, is one of 2 that started in 2026, is one of 13 with no phase, and was the 36th registered.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 777 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →5 of the 36 studies in COVID-19 by Hospices Civils de Lyon are open now, in 1 country. Each count lists the studies.
Of the 356 COVID-19 studies recruiting now, 207 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 136 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →36 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 2 started in 2026.
Median enrollment 140 across the 16 interventional studies, 238 across the 20 observational. Of the 21 that completed or were terminated, 0 (0%) have results posted.
Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
3 of the studies in COVID-19 by Hospices Civils de Lyon that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06703034Hospices Civils de LyonCharacterization of the IFN-I Response in Subjects Who Experienced Severe or Mild Forms of COVID-19 | 2027-06 |
| NCT06643039Hospices Civils de LyonNosocomial Respiratory Virus Infection | 2027-07-05 |
| NCT07302295Hospices Civils de LyonAnalysis of Suicidal Behavior Among Children and Adolescents in the Auvergne-Rhone-Alpes Region During the Covid 19 Pandemic Period | 2027-11 |
Among the 36 studies in COVID-19 by Hospices Civils de Lyon, from their registry updates:
Emerging respiratory diseases represent a global threat. Viruses such as influenza and coronaviruses have been the main drivers of pandemics over the past century. More broadly, the impact of these respiratory infections is not limited to pandemic risks. Indeed, some of them also trigger seasonal epidemics with a significant medical and economic burden. Consequently, it is essential to strengthen global surveillance, and diagnostic capacities for the pathogens responsible for respiratory infections.
The diagnosis of respiratory infections is even more important in cases of severe infection, as it helps guide and adapt patient management according to the responsible pathogen.
A promising and well-recognized approach is the analysis of exhaled breath, which contains a complex mixture of volatile organic compounds (VOCs), also known as the "volatilome." The volatilome is influenced by the patient's metabolism, immune system, and microbiome, and can be disrupted by the presence of a pathogen.
A parallel clinical study, VORTEX-1, aims to establish the performance of breath analysis for the diagnosis of respiratory infections in the context of the general population, or patient triage in emergency wards. This study targets patients with non-severe respiratory infections, mostly caused by viral pathogens.
Thanks to a specific technique, the VORTEX-1 study will make it possible to test a direct on-site sampling and analysis process, painless and with real-time chemical detection.
This methodology, highly suited to triage situations, remains difficult to apply in the case of respiratory infections requiring hospitalization. Indeed, hospitalized patients are usually admitted to different units depending on their clinical status, risk factors, or bed availability. This diversity of settings makes it impossible to implement a process that depends on an instrument which cannot be available or moved in real time across all units. To address this challenge, the investigators will use an alternative method.
In the VORTEX-2 trial, samples of exhaled gases will be collected directly at the patient's bedside using a single-use device for breath collection. The samples will then be transferred to a laboratory for analysis. This approach is more suitable for severe respiratory infections.
To be as comprehensive as possible in the study of the volatilome in the context of respiratory infections, it is important to include hospitalized patients and to develop a system that can also be implemented in routine clinical practice.
The link between the two studies (VORTEX-1 and VORTEX-2) will be established through a "control" group, consisting of healthy subjects (without respiratory infections or severe/chronic diseases), whose breath will be collected using both approaches.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 777 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
Compared within COVID-19, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Respiratory Tract Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To classify patients, an adjudication committee will base its decision on a range of clinical and biological factors: * The ICD-10 code (International Classification of Diseases, 10th revision) assigned to the patient during their treatment * Radiological examination indicating bacterial pneumonia (community-acquired pneumonia or CAP) * Biological results: * Microbiological diagnostic tools (RT-PCR tests, culture) indicating a bacterial infection. * Procalcitonin measurement (indicating a bacterial infection if \> 0.1 µg/L)
Device: Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS
To classify patients, an adjudication committee will base its decision on a range of clinical and biological factors: * The ICD-10 code (International Classification of Diseases, 10th revision) assigned to the patient during their treatment * Radiological examination not indicating bacterial pneumonia * Biological results: * Microbiological diagnostic tools (RT-PCR tests, culture) indicating a viral infection. For example, respiratory infections will be attributed to a virus if at least one of the diagnostic tests used is positive for a virus or if the interferon test shows a very high score.
Device: Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS
All patients who matched the inclusion criteria and could not be classified into groups 1 or 2 by an adjudication committee.
Device: Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS
The group of healthy volunteers, serving as the control group, will be composed of adult subjects with no respiratory symptoms or known acute or chronic pathology at the time of inclusion. They will be sampled using the same methods as the other groups in order to enable a reliable comparison of the metabolic signatures obtained.
Device: Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS
The collection and analysis of exhaled air for VOC detection is a non-invasive, painless procedure carried out offline. It can be summarised as follows: 1. Collection of 0.5-1 litre of exhaled air in a single-use Tedlar® bag 2. Transfer the exhaled air sample to a thermodesorption tube. The thermodesorption tube will be sent to the laboratory responsible for the analysis within 1-5 days of collection. 3. The breath sample will be analysed in the laboratory using thermal desorption-GC/MS. 4. Processing of the raw data to determine the chemical composition of VOCs and identify the compounds present in the exhaled air sample. 5. Statistical analysis of all generated data will be performed to identify interesting VOC profiles.
Description of the breath composition based on the area under each peak of exhaled air according to three levels of classification
Levels of classification : * Patients with bacterial or viral respiratory infection vs. no respiratory infection (healthy subjects = control group) * Patients with viral vs. bacterial respiratory infection vs. undetermined respiratory infection vs. healthy subjects * Patients with respiratory infection due to Legionella spp vs another bacterium vs SARS-CoV-2 vs influenza vs another virus vs undetermined respiratory infection vs healthy subjects
Time frame: day one
Comparison of the overall properties of the test on exhaled air with the clinical classification of a severe respiratory infection used in practice. The test will therefore aim to differentiate patients with a respiratory infection who are hospitalized w
Overall properties of the exhaled air test in comparison with the clinical classification of severe respiratory infection as used in practice.The test will aim to differentiate between hospitalised patients with a respiratory infection and a NEWS-2 score of over 4, and a control group of healthy patients. The overall performance of the test will be evaluated on several models, based on the area under the ROC curve (AUC) calculated from model predictions. Predicted AUCs will be compared to an expected AUC of 0.7 by bootstrapping
Time frame: Day one
Differentiation of the three groups of participants-those with a viral respiratory infection, those with a bacterial respiratory infection, and healthy subjects-will be evaluated using the area under the curve (AUC), in order to assess the performance
Evaluate the performance (same as secondary outcome 1) of the chemical analysis of exhaled air in differentiating between three groups of participants: those with a respiratory infection caused by a virus, those with a respiratory infection caused by bacteria, and healthy subjects.
Time frame: Day one
Evaluation of viral load in respiratory samples will be performed by retesting all nasopharyngeal samples positive for an influenza virus, SARS-CoV-2, or Legionella. This criterion will correspond to the breath composition associated with viral load.
The study will be based on the overall properties of the breath test compared with the clinical classification of severe respiratory infection used in practice. The test will therefore aim to differentiate between six groups. These performances will be evaluated using the AUC. The AUCs calculated from the predictions of each model developed will be compared to an expected AUC of 0.7 by bootstrap.
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Analyse and describe the composition of patients'' exhaled air according to viral (influenza and SARS-CoV-2) or bacterial (Legionella) load, in order to identify biomarkers whose excretion correlates with viral and bacterial load.
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Analyse and describe the composition of patients' exhaled air based on the presence of co-infection, in order to define biomarkers whose excretion is associated with these co-infections.
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Analyse and describe the composition of patients' exhaled air based on innate and adaptive immune responses in patients with and without respiratory infections. Understand any classification errors due to immune responses.
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Analyse and describe the chemical analysis of exhaled air between patients with and without an impaired type I interferon response.
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Analyse and describe the composition of patients' exhaled air based on the composition of the active respiratory microbiota (nasopharyngeal or pulmonary) in patients with and without respiratory infections. Understand any classification errors due to the composition of the active respiratory microbiota.
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Analyse and describe the composition of patients' exhaled air based on the value of the NEW2 score at inclusion.
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Analyse and describe the composition of patients' exhaled air based on three clinical progression groups: worsening, stagnation or improvement based on changes in the clinical score (NEW2).
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Analyse and describe the composition of healthy volunters' exhaled air based on online analysis process (VORTEX-1 clinical study) and the offline analysis process (VORTEX-2 clinical study).
Time frame: Day one
Plan to share: No
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