Breath Analysis for the Detection of Invasive Fungal Infections

Recruiting

• Conditions: Leukemia; Chemotherapy-induced Neutropenia; Leukemia, Lymphoblastic; Invasive Pulmonary Aspergillosis; Leukemia, Myeloid; Neutropenia; Invasive Fungal Infections
• Interventions: Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)

• Registration Number: NCT06537726
• Lead Sponsor: University of Zurich

Brief Summary

Patients with leukemia and concomitant neutropenia are at high risk of developing invasive fungal infections (IFI) that are associated with high morbidity and mortality. As these patients typically have severe thrombocytopenia, direct diagnostic sampling with invasive procedures is often not possible due to the high peri-interventional risk. Therefore, the presumptive diagnosis of IFI is primarily based on compatible lung findings on computed tomography and serologic detection of fungal cell wall components, which, however, have limited sensitivity and specificity.

With the present study, the investigators aim to determine a set of specific volatile biomarkers in leukemia patients with proven or probable IFI using secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-27
• Study First Submitted QC: 2024-08-02
• Study First Posted: 2024-08-05
• Study Start: 2024-08-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2027-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Diagnosis of acute leukemia
• Planned chemotherapy with a duration of hospitalisation of 2 weeks or longer
• Neutropenia (<500/µl) present at inclusion or planned chemotherapy with expected neutropenia (<500/µl) for more than 7 days

Exclusion Criteria

• Unable to follow instructions for breath analysis
• Anatomic abnormalities precluding the use of a mouthpiece for breath analysis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No invasive fungal disease	Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)	Patients, that retrospectively do not have evidence of IFI
Possible invasive fungal disease	Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)	Patients, that retrospectively have a possible IFI (according to EORTC guidelines). There is suspicion of IFI by clinical or radiological features, but no microbiological evidence of IFI.
Probable invasive fungal disease	Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)	Patients, that retrospectively have a probable IFI (according to EORTC guidelines). There is suspicion of IFI by clinical or radiological features, and indirect microbiological evidence of IFI.
Proven invasive fungal disease	Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)	Patients, that retrospectively have a proven IFI (according to EORTC guidelines). There is histological (angioinvasive growth of a fungus) or definitive microbiological evidence of IFI, e.g. evidence of a fungus from a sterile tissue.

Primary Outcome Measures

Name	Time	Method
Novel biomarker (m/z value) for IFI by SESI-HRMS	through study completion, on average after 3 weeks	Feature in Mass Spectrometry

Secondary Outcome Measures

Name	Time	Method
Specificity and sensitivity of this novel biomarker	through study completion, on average after 3 weeks	Description of Accuracy and Precision of this novel biomarker
Anticipation of IFI	through study completion, on average after 3 weeks	Timepoint of first detection in relation to first clinical symptoms of IFI

Trial Locations

Locations (1)

University Hospital of Zurich; 🇨🇭 Zürich, Switzerland