Respiratory Tract Infections (RTI)
Conditions
Keywords
Lower respiratory tract infections
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTBreath analysis
breath sampling and collection and analysis (microscopic analysis, cultures and syndromic panel of a respiratory sample
Sponsors
Hopital Foch
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Patients or representative unable to provide informed consent * Persons under guardianship or curatorship or persons deprived of liberty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection test | Day 0 | Breath VOC signature for patient categorical classification of LRTI (infection / colonization / none) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathogen class test | Day 0 | Breath VOC signature differentiating bacterial and viral infections |
| Pathogen ID test | Day | Breath VOC signature differentiating major respiratory pathogens |
| Diagnostic performance | Day 0 | Sensitivity, specificity, negative predictive value, positive predictive value, area under the ROC curve, accuracy of each test compared to reference standards |
| Antimicrobial susceptibility test | Day 0 | Breath VOC signature differentiating susceptibility and resistance of a given pathogen to a given antibiotic (exploratory outcome). |
Countries
France
Contacts
CONTACTStanislas Grassin Delyle
CONTACTVirginie Guitard
Outcome results
None listed