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Recruiting NCT06537726

Breath Analysis for the Detection of Invasive Fungal Infections

Trial Parameters

Condition Leukemia
Sponsor University of Zurich
Study Type OBSERVATIONAL
Phase N/A
Enrollment 130
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-08-19
Completion 2027-10-31
Interventions
Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)

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).

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

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