Actively Recruiting
Real-time Breath Analysis for the Detection of Invasive Fungal Infections in Neutropenic High-risk Patients
Led by University of Zurich · Updated on 2025-04-10
130
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with leukemia and neutropenia are at high risk for invasive fungal infections (IFI), which can lead to serious health problems and high mortality. Due to severe thrombocytopenia, invasive diagnostic procedures are often too risky for these patients. Diagnosis usually relies on lung findings from computed tomography and serologic tests for fungal components, but these methods have limited accuracy. This research aims to identify specific volatile biomarkers in the breath of leukemia patients with proven or probable IFI using a technology called secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS). The study observes patients grouped by their IFI status according to EORTC guidelines: no IFI, possible IFI (clinical or radiological suspicion without microbiological proof), probable IFI (clinical or radiological suspicion with indirect microbiological evidence), and proven IFI (definitive histological or microbiological evidence). The investigational approach involves analyzing patients’ breath samples with SESI-HRMS to detect volatile biomarkers linked to IFI. Participants will provide breath samples during their hospital stay, typically lasting two weeks or longer due to chemotherapy. Researchers will measure novel biomarkers in breath over about three weeks to evaluate their ability to detect IFI. They will assess the sensitivity and specificity of these biomarkers and how early IFI can be anticipated. The study is observational, focusing on collecting and analyzing breath metabolome data without altering patient treatment.
CONDITIONS
Brief Title
Breath Analysis for the Detection of Invasive Fungal Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute leukemia
- Planned chemotherapy with a hospitalization of 2 weeks or longer
- Neutropenia (less than 500/µl) present at inclusion or expected neutropenia for more than 7 days during chemotherapy
You will not qualify if you...
- Unable to follow instructions for breath analysis
- Anatomic abnormalities preventing use of a mouthpiece for breath analysis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks
Participants undergo breath analysis using secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS) to identify volatile biomarkers related to invasive fungal infections.
Multiple breath analysis sessions during hospitalization
Duration - Through study completion, on average after 3 weeks
Participants are observed for the presence or absence of invasive fungal infections based on breath analysis results and clinical assessments.
Follow-up assessments as determined by clinical care
Trial Site Locations
Total: 1 location
1
University Hospital of Zurich
Zurich, Canton of Zurich, Switzerland, 8091
Actively Recruiting
Research Team
J
Jeremy Deuel, PD Dr.
K
Kevin Hofer, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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