Breath Analysis for the Detection of Invasive Fungal Infections

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Zurich

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unable to follow instructions for breath analysis

Anatomic abnormalities precluding the use of a mouthpiece for breath analysis

Trial population

Patients with acute leukemia that are undergoing chemotherapy at the Department of Medical Oncology and Haematology at the University Hospital Zurich

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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

    Diagnostic test

    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.

Treatment groups

130 Participants
are divided into 4 treatment groups
Group A: No invasive fungal disease1 intervention
Group B: Possible invasive fungal disease1 intervention
Group C: Probable invasive fungal disease1 intervention
Group D: Proven invasive fungal disease1 intervention

Trial outcomes

Primary outcomes

1

Novel biomarker (m/z value) for IFI by SESI-HRMS

Feature in Mass Spectrometry

Time frame
through study completion, on average after 3 weeks

Secondary outcomes

1

Specificity and sensitivity of this novel biomarker

Description of Accuracy and Precision of this novel biomarker

Time frame
through study completion, on average after 3 weeks
2

Anticipation of IFI

Timepoint of first detection in relation to first clinical symptoms of IFI

Time frame
through study completion, on average after 3 weeks

Other outcomes

Sponsors and contacts

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