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NCT06537726Recruiting

Breath Analysis for the Detection of Invasive Fungal Infections

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).

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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
—
Study type
Observational
Countries
Switzerland
Sponsor
University of Zurich(Other)
Protocol no.
SNCTP000005947
Conditions
Leukemia, Leukemia, Myeloid, Leukemia, Lymphoblastic, Neutropenia, Chemotherapy-induced Neutropenia, Invasive Fungal Infections, Invasive Pulmonary Aspergillosis
Interventions
Diagnostic test

Treatments studied

  • Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)

Locations · 1

  • Zurich, SwitzerlandUniversity Hospital of ZurichRecruiting at this site

In total, worldwide, the only site listed in the registry is recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: April 10, 2025).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.