Respiratory Tract Infections (RTI)RespireNCT07685275
Real-Time Mass Spectrometry Breath Analysis for the Investigation of Respiratory Tract Infections
A study testing Breath analysis in people with Respiratory Tract Infections (RTI), run by Hopital Foch at 3 sites in France.
Trial summary
Lower respiratory tract infections (LRTIs) remain a major global health burden, with diagnosis often challenged by clinical heterogeneity, overlapping symptoms, difficulty in obtaining quality biological specimens and limitations of conventional microbiological testing. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Respiratory Tract Infections (RTI)
- What is being tested?
- Breath analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 3 sitesFrance
- Study dates
- 30 Jun 2026to 30 Dec 2027
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient aged > 1 month, either spontaneously breathing or intubated and mechanically ventilated
- Having suspected lower respiratory tract infection (dyspnea or tachypnea or cough or sputum production or fever or decreased breath sounds on auscultation or any other suspicious diagnostic test (imaging, blood analysis)) or previously documented chronic airway colonization
- Willing to provide informed consent and affiliated with a health insurance system
Who cannot join
- Patients or representative unable to provide informed consent
- Persons under guardianship or curatorship or persons deprived of liberty
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Hôpital Raymond Poincaré
Garches, 92380
Djillali Annane, MD PhD, +33 1 47 10 77 87, djillali.annane@aphp.fr
Hôpital Necker
Paris, 75015
Isabelle Sermet-Gaudelus, +33 1 44 49 48 87, isabelle.sermet@aphp.fr
Hôpital Foch
Suresnes, 92150
Hélène Salvator, +33 1 46 25 29 55, h.salvator@hopital-foch.com
About this study
Lower respiratory tract infections (LRTIs) remain a major global health burden, with diagnosis often challenged by clinical heterogeneity, overlapping symptoms, difficulty in obtaining quality biological specimens and limitations of conventional microbiological testing. Exhaled breath contains thousands of volatile organic compounds (VOCs), arising from both host metabolism and microbial activity, and provides a non-invasive window into the metabolic landscape of infection. Emerging evidence from in vitro studies, animal models, and clinical investigations supports the existence of pathogen-specific VOC signatures. However, most published studies have relied on offline methods, such as gas chromatography-mass spectrometry (GC-MS), and robust proof-of-concept for real-time, bedside analysis in diverse, real-world populations is lacking. Proton transfer reaction-mass spectrometry (PTR-MS) offers rapid, quantitative, and non-invasive assessment of breath VOCs in both spontaneously breathing and mechanically ventilated patients.
- Conditions
- Respiratory Tract Infections (RTI)
- Being tested
- Breath analysis
- Keywords
- Lower respiratory tract infections
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath analysisDiagnostic test
breath sampling and collection and analysis (microscopic analysis, cultures and syndromic panel of a respiratory sample
| Study group | Role | What they receive |
|---|---|---|
| Breath analysis | Experimental | Breath analysis and respiratory sample collection Receives: Diagnostic Test: Breath analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection test
Breath VOC signature for patient categorical classification of LRTI (infection / colonization / none)
Measured: Day 0
Secondary outcomes (4)
Pathogen class test
Breath VOC signature differentiating bacterial and viral infections
Measured: Day 0
Pathogen ID test
Breath VOC signature differentiating major respiratory pathogens
Measured: Day
Diagnostic performance
Sensitivity, specificity, negative predictive value, positive predictive value, area under the ROC curve, accuracy of each test compared to reference standards
Measured: Day 0
Antimicrobial susceptibility test
Breath VOC signature differentiating susceptibility and resistance of a given pathogen to a given antibiotic (exploratory outcome).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract Infections (RTI)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685275
- Sponsor's protocol ID
- 2025_0378
- Acronym
- Respire
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Mass Spectrometry Breath Analysis for the Investigation of Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT07685275
- Acronym / sponsor ID
- Respire / 2025_0378
- Conditions
- Respiratory Tract Infections (RTI)
- Keywords
- Lower respiratory tract infections
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 6 Jul 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.
Lower respiratory tract infections (LRTIs) remain a major global health burden, with diagnosis often challenged by clinical heterogeneity, overlapping symptoms, difficulty in obtaining quality biological specimens and limitations of conventional microbiological testing. Exhaled breath contains thousands of volatile organic compounds (VOCs), arising from both host metabolism and microbial activity, and provides a non-invasive window into the metabolic landscape of infection. Emerging evidence from in vitro studies, animal models, and clinical investigations supports the existence of pathogen-specific VOC signatures. However, most published studies have relied on offline methods, such as gas chromatography-mass spectrometry (GC-MS), and robust proof-of-concept for real-time, bedside analysis in diverse, real-world populations is lacking. Proton transfer reaction-mass spectrometry (PTR-MS) offers rapid, quantitative, and non-invasive assessment of breath VOCs in both spontaneously breathing and mechanically ventilated patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breath analysis | Experimental | Diagnostic Test: Breath analysisBreath analysis and respiratory sample collection |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged > 1 month, either spontaneously breathing or intubated and mechanically ventilated
- Having suspected lower respiratory tract infection (dyspnea or tachypnea or cough or sputum production or fever or decreased breath sounds on auscultation or any other suspicious diagnostic test (imaging, blood analysis)) or previously documented chronic airway colonization
- Willing to provide informed consent and affiliated with a health insurance system
Key exclusion criteria (2 listed)
- Patients or representative unable to provide informed consent
- Persons under guardianship or curatorship or persons deprived of liberty
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 |
|---|---|---|
| Breath analysisbreath sampling and collection and analysis (microscopic analysis, cultures and syndromic panel of a respiratory sample | Diagnostic test | Breath analysis |
Primary outcome
Infection test
Time frame: Day 0
Breath VOC signature for patient categorical classification of LRTI (infection / colonization / none)
4 secondary outcomes
Pathogen class test
Time frame: Day 0
Pathogen ID test
Time frame: Day
Diagnostic performance
Time frame: Day 0
Antimicrobial susceptibility test
Time frame: Day 0
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 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath analysis in people with Respiratory Tract Infections (RTI), run by Hopital Foch at 3 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 3 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: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 Stanislas Grassin Delyle (+33 1 46 25 73 93, s.grassindelyle@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection test (time frame: Day 0). 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 6 Jul 2026.