An observational study in Mucorales Infection and Mucormycosis, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged 3 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by University Hospital, Lille · Observational
Mucormycosis (MM) is one of the main invasive fungal infection (IFI), and is determined by filamentous fungi belonging to the order of Mucorales, with a mortality rate ranging from 20 to 60% according to localization. Prompt initiation of adequate antifungal therapy is critical for treating mucormycosis. Early diagnostic is therefore essential. The presence in the Mucorales' cell wall of uncommon monosaccharides open interesting perspectives for the development of specific diagnostic biomarkers.
This study evaluate a diagnostic test for mucormycosis in a cohort of patients with MM and in control groups (high-risk patients without MM and patients with another IFI).
32 studies on the registry are indexed under Mucormycosis; 8 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 19 observational studies indexed under Mucormycosis.
Browse Mucormycosis studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients cared for at the University Hospitals of Lille and Amiens (France)
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Specific medical conditions :
For the case group :
Any patient hospitalized in one of the departments of the University Hospital of Lille, in which the diagnosis of mucormycosis was conducted on the following criteria:
Exclusion Criteria:
Age : from 3 to 75 years old ; \- Specific medical conditions : patient hospitalized in one of the departments of the University Hospital of Lille or Amiens, in whom the diagnosis of mucormycosis will have been made on the criteria below, with compatible clinical and radiological evolution : * conventional mycology data and/or * positive q-PCR and/or * pathology data confirmed by PCR;
Biological: Venous sample
Age : from 18 to 75 ; \- Specific medical conditions : patients hospitalized at the University Hospital of Lille or Amiens for whom a diagnosis of candidiasis or invasive aspergillosis has been made according to specific classifications (EORTC/MSG criteria, AspICU criteria)
Biological: Venous sample
* Age : from 18 to 75 ; * Specific medical conditions : patients undergoing assessment for haematopoietic stem cell transplantation, considered at risk of invasive fungal infection but for whom the pre-transplant assessment will have excluded an ongoing infection.
Biological: Venous sample
at Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day
Values of the biomarker studied in the patient group versus control groups, expressed as Optical density (OD).
Detection and quantification of the oligosaccharide biomarker will be performed using a sandwich type enzyme-linked immunosorbent assay (ELISA).Biomarker values could also be reported in arbitrary units / mL (plotting the calibration curve).
Time frame: at Day 0
Kinetics of the biomarker value measured for hospitalized patients, expressed as Optical density (OD).
At each day of interest (at Day 3, Day 7, Day 14 and Day 28), values of OD obtained with an in-house immunoenzymatic sandwich microplate assay for the detection of a specific carbohydrate epitope of Mucorales will be reported for each sera.
Time frame: at Day 3, Day 7, Day 14 and Day 28
Number of participant with unfavorable clinical evolution (death at D28)
Description of the clinical evolution (death or survival at D28) in parallel with the kinetic of the biomarker value
Time frame: at day 28
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