Real-time Breath Test to Detect Invasive Fungal Infections in Adults with Leukemia and Neutropenia

What this Trial Is About

Patients with leukemia and neutropenia are at high risk for invasive fungal infections IFI, which can lead to serious health problems and high mortality. Due to severe thrombocytopenia, invasive diagnostic procedures are often too risky for these patients. Diagnosis usually relies on lung findings from computed tomography and serologic tests for fungal components, but these methods have limited accuracy. This research aims to identify specific volatile biomarkers in the breath of leukemia patients with proven or probable IFI using a technology called secondary electrospray ionization high-resolution mass spectrometry SESI-HRMS. The study observes patients grouped by their IFI status according to EORTC guidelines no IFI, possible IFI clinical or radiological suspicion without microbiological proof, probable IFI clinical or radiological suspicion with indirect microbiological evidence, and proven IFI definitive histological or microbiological evidence. The investigational approach involves analyzing patients breath samples with SESI-HRMS to detect volatile biomarkers linked to IFI. Participants will provide breath samples during their hospital stay, typically lasting two weeks or longer due to chemotherapy. Researchers will measure novel biomarkers in breath over about three weeks to evaluate their ability to detect IFI. They will assess the sensitivity and specificity of these biomarkers and how early IFI can be anticipated. The study is observational, focusing on collecting and analyzing breath metabolome data without altering patient treatment.

Breath Analysis for the Detection of Invasive Fungal Infections