RecruitingNCT06537726

Breath Analysis for the Detection of Invasive Fungal Infections

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


Sponsor

University of Zurich

Enrollment

130 participants

Start Date

Aug 19, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria2

  • Unable to follow instructions for breath analysis
  • Anatomic abnormalities precluding the use of a mouthpiece for breath analysis

Interventions

DIAGNOSTIC_TESTSecondary 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.


Locations(1)

University Hospital of Zurich

Zurich, Canton of Zurich, Switzerland

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NCT06537726


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