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ClinicalTrials.gov ID

NCT07685275

Lead Sponsor

Hopital FochOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

450Estimated

Last Update Posted

Jul 6, 2026Actual

Start Date

Jun 30, 2026Estimated

Primary Completion Date

Dec 30, 2027Estimated

Completion Date

Dec 30, 2027Estimated

Official Title

Real-Time Mass Spectrometry Breath Analysis for the Investigation of 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.

• Respiratory Tract Infections (RTI)

• Breath analysis

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Hopital FochOTHER

isabelle.sermet@aphp.fr+33 1 44 49 48 87

h.salvator@hopital-foch.com+33 1 46 25 29 55