Breath Analysis for the Detection of Invasive Fungal Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS).
- Who it may be relevant to
- Registry conditions: Leukemia, Leukemia, Myeloid, Leukemia, Lymphoblastic, Neutropenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real-time Breath Analysis for the Detection of Invasive Fungal Infections in Neutropenic High-risk Patients
Overview
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).
Interventions
- Diagnostic test Secondary 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.
Primary outcome measures
- Novel biomarker (m/z value) for IFI by SESI-HRMS [Time frame: through study completion, on average after 3 weeks]
Secondary outcome measures (2)
- Specificity and sensitivity of this novel biomarker [Time frame: through study completion, on average after 3 weeks]
- Anticipation of IFI [Time frame: through study completion, on average after 3 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Switzerland · 1 center
- University Hospital of Zurich — Zurich
Identifiers
NCT: NCT06537726 · SNCTP000005947