Diagnostic Marker of Mucormycosis: Development and Evaluation of a Diagnostic Assay on a Cohort of Sera

What this Trial Is About

Researchers are evaluating a new diagnostic test for mucormycosis, a serious invasive fungal infection caused by fungi in the Mucorales order. This infection has a high mortality rate between 20% and 60% depending on its location. Early diagnosis and prompt antifungal treatment are critical. The study focuses on detecting specific biomarkers found in the fungal cell wall to improve diagnosis accuracy among patients with mucormycosis and control groups including high-risk patients without mucormycosis and those with other invasive fungal infections. The study involves three groups: patients diagnosed with mucormycosis, high-risk patients without mucormycosis assessed before hematopoietic stem cell transplantation, and patients with other invasive fungal infections like candidiasis or aspergillosis. Venous blood samples are collected at multiple time points: Day 0 (diagnosis day), Day 3, Day 7, Day 14, and Day 28 to measure biomarker levels. These measures aim to assess the presence and changes of the biomarker over time. Participants will undergo regular blood sampling and clinical evaluation during hospitalization. The main outcome is the biomarker values measured as optical density on Day 0, with follow-up measurements on Days 3, 7, 14, and 28 to observe biomarker kinetics. Researchers will also track clinical outcomes such as death at 28 days. The total participation duration varies but includes assessments through the first 28 days after diagnosis or enrollment.

Biomarkers for Invasive Mucormycosis