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Recruiting Observational

Breath Analysis for the Detection of Invasive Fungal Infections

NCT06537726 · tracked via the Priya Life Science Switzerland tracker
Phase
Observational
Started
2024-08-19
Last updated
2025-04-10

Condition(s) studied

LeukemiaLeukemia, MyeloidLeukemia, LymphoblasticNeutropeniaChemotherapy-induced NeutropeniaInvasive Fungal InfectionsInvasive Pulmonary Aspergillosis

Investigational drug(s) / intervention(s)

Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)

Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS): Identify volatile biomarkers of IFI by analyzing the breath metabolome of patients with proven or probable IFI according to the criteria outlined by EORTC/MSG and controls.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Zurich Zurich Canton of Zurich Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06537726 on ClinicalTrials.gov ↗ ← All trials in Switzerland