Breath Analysis for the Detection of Invasive Fungal Infections (REDEFINE)

University of Zurich (UZH)

Status: Enrolling

Conditions: Chemotherapy-induced Neutropenia; Invasive Fungal Infections; Invasive Pulmonary Aspergillosis; Neutropenia; Leukemia, Lymphoblastic; Leukemia; Leukemia, Myeloid

Treatments: Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)

Study type: Observational

Funder types: Other

Identifiers

NCT06537726

SNCTP000005947

Details and patient eligibility

About

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).

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

130 participants in 4 patient groups

No invasive fungal disease

Description:

Patients, that retrospectively do not have evidence of IFI

Treatment:

Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)

Possible invasive fungal disease

Description:

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.

Treatment:

Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)

Probable invasive fungal disease

Description:

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.

Treatment:

Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)

Proven invasive fungal disease

Description:

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.

Treatment:

Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)