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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
University Hospital of Zurich
RECRUITING
Zurich
Contact Information
Primary
Jeremy Deuel, PD Dr.
jeremy.deuel@usz.ch
+41 44 255 11 11
Backup
Kevin Hofer, Dr.
kevin.hofer@usz.ch
+41 44 255 11 11
Time Frame
Start Date: 2024-08-19
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 130
Treatments
No invasive fungal disease
Patients, that retrospectively do not have evidence of IFI
Possible invasive fungal disease
Patients, that retrospectively have a possible IFI (according to EORTC guidelines). There is suspicion of IFI by clinical or radiological features, but no microbiological evidence of IFI.
Probable invasive fungal disease
Patients, that retrospectively have a probable IFI (according to EORTC guidelines). There is suspicion of IFI by clinical or radiological features, and indirect microbiological evidence of IFI.
Proven invasive fungal disease
Patients, that retrospectively have a proven IFI (according to EORTC guidelines). There is histological (angioinvasive growth of a fungus) or definitive microbiological evidence of IFI, e.g. evidence of a fungus from a sterile tissue.
Sponsors
Leads: University of Zurich

This content was sourced from clinicaltrials.gov