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Recruiting

Breath Analysis for the Detection of Invasive Fungal Infections

NCT06537726 · University of Zurich
In plain English

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Official title
Real-time Breath Analysis for the Detection of Invasive Fungal Infections in Neutropenic High-risk Patients
About this study
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 criteria
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
Enrollment target: 130 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-08-19
Estimated completion: 2027-10-31
Last updated: 2025-04-10
Interventions
Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
Primary outcomes
  • Novel biomarker (m/z value) for IFI by SESI-HRMS (through study completion, on average after 3 weeks)
Sponsor
University of Zurich · other
Contacts & investigators
ContactJeremy Deuel, PD Dr. · contact · jeremy.deuel@usz.ch · +41 44 255 11 11
ContactKevin Hofer, Dr. · contact · kevin.hofer@usz.ch · +41 44 255 11 11
InvestigatorJeremy Deuel, PD Dr. · principal_investigator, University of Zurich
All locations (1)
University Hospital of ZurichRecruiting
Zurich, Canton of Zurich, Switzerland
Breath Analysis for the Detection of Invasive Fungal Infections · TrialPath