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

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 Overview

• Status: Not yet recruiting
• Conditions: Respiratory Tract Infections (RTI)
• Intervention / Treatment: Diagnostic test: Breath analysis

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stanislas Grassin Delyle; Phone Number: +33 1 46 25 73 93; Email: s.grassindelyle@hopital-foch.com
• Study Contact Backup: Name: Virginie Guitard; Phone Number: +33 1 46 25 73 88; Email: drci-promotion@hopital-foch.com

Study Locations

• France
  • Garches, France, 92380
    • Hopital Raymond Poincare
    • Contact: Djillali Annane, MD PhD; Phone Number: +33 1 47 10 77 87; Email: djillali.annane@aphp.fr
  • Paris, France, 75015
    • Hopital Necker
    • Contact: Isabelle Sermet-Gaudelus; Phone Number: +33 1 44 49 48 87; Email: isabelle.sermet@aphp.fr
  • Suresnes, France, 92150
    • Hopital Foch
    • Contact: Hélène Salvator; Phone Number: +33 1 46 25 29 55; Email: h.salvator@hopital-foch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breath analysis; Breath analysis and respiratory sample collection	Diagnostic test: Breath analysis; breath sampling and collection and analysis (microscopic analysis, cultures and syndromic panel of a respiratory sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection test	Breath VOC signature for patient categorical classification of LRTI (infection / colonization / none)	Day 0

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Lower respiratory tract infections
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Diagnostic Techniques and Procedures; Diagnosis; Breath Tests
• Other Study ID Numbers: 2025_0378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No