Respiratory InfectionsVORTEX-2NCT07352462
Volatile Organic Compounds Analysis by GC-MS for Diagnostic of Hospitalised Patients With Respiratory Infections Using Exhaled Breath
A study testing Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS in people with Respiratory Infections and COVID-19, run by Hospices Civils de Lyon at 7 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Infections, COVID-19, Influenza Virus Infection
- What is being tested?
- Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 777 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Jan 2026to 3 Feb 2029
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Having signed a written informed consent
- Presenting a NEWS-2 score of 5 (>4) or one of the individual score criteria rated 3
- Hospitalized in one of the HCL (Hospices Civils de Lyon) departments participating in the study
- With clinical signs of acute respiratory infection, or with a clinical presentation of acute community-acquired pneumonia, nasopharyngitis, angina or laryngitis (except for healthy patients)
Who cannot join
- Healthy volunteers:
- Age: < 18 years
- Alcohol consumption less than 12 hours
- Person with co-morbidities such as chronic respiratory failure, type II diabetes, cancerous processes, chronic liver disease, chronic kidney disease
- Clinical signs of acute respiratory infection
- Persons who are unable to blow into exhaled-air analysis devices (in accordance with instructions for use)
Show all 26Show fewer
- Persons under legal protection
- Pregnant women, women in labor or nursing mothers
- Persons deprived of their liberty by judicial or administrative decision
- Persons under psychiatric care
- Persons admitted to a health or social institution for purposes other than research
- Adults under legal protection (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- Patients with respiratory symptoms
- Age: < 18 years
- Patients whose symptoms have been present for more than 7 days
- Persons unable to blow into the device for breath analysis (in accordance with the operating instructions)
- Patients suffering from cystic fibrosis
- Patients with severe chronic respiratory insufficiency requiring long-term oxygen therapy or NIV (non-invasive ventilation), excluding CPAP (Continuous Positive Airway Pressure) for sleep apnea
- Patients under legal protection
- Pregnant women, women in labor or nursing mothers
- Persons deprived of their liberty by judicial or administrative decision
- Persons under psychiatric care
- Persons admitted to a health or social institution for purposes other than research
- Adults under legal protection (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
Emergency department (Hôpital de la Croix-Rousse, Hospices Civils de Lyon)
Lyon, 69004
Pr Youri YORDANOV, MD, PhD, youri.yordanov@chu-lyon.fr
Infectious Disease Service of Hôpital de la Croix-Rousse (Hospices Civils de Lyon)
Lyon, 69004
Florence ADER, MD, PhD, florence.ader@chu-lyon.fr
Intensive Care Unit of Hôpital de la Croix-Rousse (Hospices Civils de Lyon)
Lyon, 69004
Jean-Christophe RICHARD, MD, PhD, j-christophe.richard@chu-lyon.fr
Intensive Care Unit of Hôpital Lyon Sud (Hospices Civils de Lyon)
Lyon, 69004
Arnaud FRIGGERI, MD, PhD, arnaud.friggeri@chu-lyon.fr
Internal Medecine Unit of Hôpital de la Croix-Rousse (Hospices Civils de Lyon)
Lyon, 69004
Pascal SEVE, MD, PhD, pascal.seve@chu-lyon.fr
National reference center for respiratory viruses (Hôpital de la Croix-Rousse, Hospices Civils de Lyon)
Lyon, 69004
Alexandre GAYMARD, PharmD, PhD, alexandre.gaymard@chu-lyon.fr
Pneumology Unit of Hôpital de la Croix-Rousse (Hospices Civils de Lyon)
Lyon, 69004
Eloise ALABADAN, MD, PhD, eloise.alabadan@chu-lyon.fr
About this study
Official title: Volatile Organic Compounds Analysis for Rapid Testing Using EXhaled Breath for Respiratory Infection in Hospitalised Patients
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.
Read more
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.
- Conditions
- Respiratory Infections, COVID-19, Influenza Virus Infection, Legionella Pneumophila Infections
- Being tested
- Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS
- Keywords
- Pandemic preparedness, Volatilome, Breath research, Respiratory infections, Diagnosis
- Medical subject headings
- Respiratory Tract Infections, COVID-19, Legionnaires' Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MSDevice
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:
- Collection of 0.5-1 litre of exhaled air in a single-use Tedlar® bag
- 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.
- The breath sample will be analysed in the laboratory using thermal desorption-GC/MS.
- Processing of the raw data to determine the chemical composition of VOCs and identify the compounds present in the exhaled air sample.
- Statistical analysis of all generated data will be performed to identify interesting VOC profiles.
| Study group | Role | What they receive |
|---|---|---|
| Bacterial respiratory infection | Experimental | 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) Receives: Device: Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS |
| Viral respiratory infection | Experimental | 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. Receives: Device: Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS |
| Undetermined respiratory infection | Experimental | All patients who matched the inclusion criteria and could not be classified into groups 1 or 2 by an adjudication committee. Receives: Device: Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS |
| Healthy patients | Placebo comparator | 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. Receives: Device: Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day one
Secondary outcomes (11)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion3 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a cross-sectional diagnostic study using case-control sampling, where the number of cases and non-cases is fixed in advance, and a gold standard comparison is used. 0
- Masking
- None (open label)
- Enrolment
- 777 participants (estimated)
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
- NCT07352462
- Sponsor's protocol ID
- 69HCL25_0600
- Other IDs
- 2025-A01544-45
- Acronym
- VORTEX-2
- Status last verified
- Jan 2026
- First submitted
- 28 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volatile Organic Compounds Analysis for Rapid Testing Using EXhaled Breath for Respiratory Infection in Hospitalised Patients
- ClinicalTrials.gov ID
- NCT07352462
- Acronym / sponsor ID
- VORTEX-2 / 69HCL25_0600
- Conditions
- Respiratory Infections, COVID-19, Influenza Virus Infection, Legionella Pneumophila Infections
- Keywords
- Pandemic preparedness, Volatilome, Breath research, Respiratory infections, Diagnosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 777 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 3 Feb 2029 (estimated)
- First posted
- 20 Jan 2026 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a cross-sectional diagnostic study using case-control sampling, where the number of cases and non-cases is fixed in advance, and a gold standard comparison is used. 0
| Arm | Type | Receives |
|---|---|---|
| Bacterial respiratory infection | Experimental | Device: Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MSTo 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) |
| Viral respiratory infection | Experimental | Device: Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MSTo 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. |
| Undetermined respiratory infection | Experimental | Device: Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MSAll patients who matched the inclusion criteria and could not be classified into groups 1 or 2 by an adjudication committee. |
| Healthy patients | Placebo comparator | Device: Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MSThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- Having signed a written informed consent
- Presenting a NEWS-2 score of 5 (>4) or one of the individual score criteria rated 3
- Hospitalized in one of the HCL (Hospices Civils de Lyon) departments participating in the study
- With clinical signs of acute respiratory infection, or with a clinical presentation of acute community-acquired pneumonia, nasopharyngitis, angina or laryngitis (except for healthy patients)
Key exclusion criteria (26 listed)
- Healthy volunteers:
- Age: < 18 years
- Alcohol consumption less than 12 hours
- Person with co-morbidities such as chronic respiratory failure, type II diabetes, cancerous processes, chronic liver disease, chronic kidney disease
- Clinical signs of acute respiratory infection
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 |
|---|---|---|
| Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MSThe 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. | Device | Bacterial respiratory infection, Healthy patients, Undetermined respiratory infection, Viral respiratory infection |
Primary outcome
Description of the breath composition based on the area under each peak of exhaled air according to three levels of classification
Time frame: day one
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
11 secondary outcomes
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
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
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.
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Time frame: Day one
Description of the breath composition based on the AUC of each peak
Time frame: Day one
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 20 Jan 2026.
- Individual participant dataSharing planned: No
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volatile Organic compounds (VOC) analysis in Exhaled breath using GC-MS in people with Respiratory Infections and COVID-19, run by Hospices Civils de Lyon at 7 sites 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 26 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. Some participants in this study may receive a placebo. 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?
Contact Dr Alexandre GAYMARD (+4 72 07 10 53, alexandre.gaymard@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the breath composition based on the area under each peak of exhaled air according to three levels of classification (time frame: day one). 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 20 Jan 2026.