Breath Analysis for the Detection of Invasive Fungal Infections

NCT06537726 — Recruiting, 130 participants, University of Zurich

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Real-time Breath Analysis for the Detection of Invasive Fungal Infections in Neutropenic High-risk Patients

Registry	NCT06537726, acronym REDEFINE
Status	Recruiting
Study type	Observational
Enrollment	130 (Estimated)
Sponsor	University of Zurich (Other)
Conditions	Leukemia, Leukemia, Myeloid, Leukemia, Lymphoblastic, Neutropenia, Chemotherapy-induced Neutropenia, Invasive Fungal Infections, Invasive Pulmonary Aspergillosis
Interventions	Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS) (Diagnostic test)
Dates	start 2024-08-19, primary completion 2027-10-31 (estimated), completion 2027-10-31 (estimated), first posted 2024-08-05, last updated 2025-04-10
Locations	1 site in Switzerland

-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).

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+Arms and interventions

Arm	Interventions	Description
No invasive fungal disease	Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)	Patients, that retrospectively do not have evidence of IFI
Possible invasive fungal disease	Diagnostic Test: 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	Diagnostic Test: 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	Diagnostic Test: 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.

Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS) (Diagnostic test), also known as Blood sampling (serologic biomarkers, PCR), Sputum analysis, Low-dose CT: 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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
University Hospital of Zurich	Zurich, Canton of Zurich	Switzerland	Recruiting

+Investigators

Jeremy Deuel, PD Dr., Principal investigator, University of Zurich

My Notes

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