NCT06537726

Breath Analysis for the Detection of Invasive Fungal Infections

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Leukemia
• Leukemia, Myeloid
• Leukemia, Lymphoblastic
• Neutropenia
• Chemotherapy-induced Neutropenia
• Invasive Fungal Infections
• Invasive Pulmonary Aspergillosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-19
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2024-08-05
• Last updated: 2025-04-10

Locations

1 site across 1 country: Switzerland