Real-Time Mass Spectrometry Breath Analysis for the Investigation of Respiratory Tract Infections

NCT07685275 | Not Yet Recruiting

• 1 other identifier: 2025_0378
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 3

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.

Conditions

Respiratory Tract Infections (RTI)

Keywords

Lower respiratory tract infections

Outcome Measures

Primary Outcomes (1)

• Infection test

  Breath VOC signature for patient categorical classification of LRTI (infection / colonization / none)

  Day 0

Secondary Outcomes (4)

• Pathogen class test

  Day 0

• Pathogen ID test

  Day

• Diagnostic performance

  Day 0

• Antimicrobial susceptibility test

  Day 0

Study Arms (1)

Breath analysis

EXPERIMENTAL

Breath analysis and respiratory sample collection

Diagnostic Test: Breath analysis

Interventions

Breath analysis DIAGNOSTIC_TEST

breath sampling and collection and analysis (microscopic analysis, cultures and syndromic panel of a respiratory sample

Breath analysis

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients or representative unable to provide informed consent
• Persons under guardianship or curatorship or persons deprived of liberty

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (3)

Hôpital Raymond Poincaré

Garches, 92380, France

Location

Hôpital Necker

Paris, 75015, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Breath Tests

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Locations

FR (3)