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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breath analysis | Experimental | Breath analysis and respiratory sample collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breath analysis | Diagnostic Test | breath sampling and collection and analysis (microscopic analysis, cultures and syndromic panel of a respiratory sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infection test | Breath VOC signature for patient categorical classification of LRTI (infection / colonization / none) | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Pathogen class test | Breath VOC signature differentiating bacterial and viral infections | Day 0 |
| Pathogen ID test | Breath VOC signature differentiating major respiratory pathogens |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stanislas Grassin Delyle | Contact | +33 1 46 25 73 93 | s.grassindelyle@hopital-foch.com | |
| Virginie Guitard | Contact | +33 1 46 25 73 88 | drci-promotion@hopital-foch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Raymond Poincaré | Garches | 92380 | France |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001944 | Breath Tests |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Day |
| Diagnostic performance | Sensitivity, specificity, negative predictive value, positive predictive value, area under the ROC curve, accuracy of each test compared to reference standards | Day 0 |
| Antimicrobial susceptibility test | Breath VOC signature differentiating susceptibility and resistance of a given pathogen to a given antibiotic (exploratory outcome). | Day 0 |
| Hôpital Necker | Paris | 75015 | France |
|
| Hôpital Foch | Suresnes | 92150 | France |
|