Mucorales Infection, Mucormycosis
Conditions
Keywords
Mucormycosis, Invasive fungal infection, Cell wall oligo/polysaccharides, Biomarkers
Brief summary
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).
Interventions
BIOLOGICALVenous sample
at Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day
Sponsors
University Hospital, Lille
Plateforme PAGés, Analyses Glycoconjugués
Région Hauts de France, France
SATT Nord
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women * Age : Children and adults from 3 to 64 years old (18 to 64 for controls) * In patients whose consent has been collected after information. In the case of children, information on the study will be given to the holders of parental authority and then to the child to obtain their consent. * Patient social insured * Specific medical conditions : 1. 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: * Conventional mycology data and / or * Positivity of q-PRC and / or * Anatomopathologic diagnosis Associated with a compatible clinical situation 2. For the control group 1 Patient assessed for hematopoietic stem cell transplantation, considered at risk for IFI but for whom the pre-transplantation review will have excluded an ongoing infection 3. For control group 2 Any patient hospitalized in a department of Lille University Hospital, in which the diagnosis of disseminated candidiasis or invasive pulmonary aspergillosis has been made according to specific classifications (EORTC/MSG criteria, AspICU criteria)
Exclusion criteria
* Patients for whom the inclusion criteria are not met * Co-infection mucormycosis/other IFI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Values of the biomarker studied in the patient group versus control groups, expressed as Optical density (OD). | at Day 0 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kinetics of the biomarker value measured for hospitalized patients, expressed as Optical density (OD). | at Day 3, Day 7, Day 14 and Day 28 | 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. |
| Number of participant with unfavorable clinical evolution (death at D28) | at day 28 | Description of the clinical evolution (death or survival at D28) in parallel with the kinetic of the biomarker value |
Countries
France
Contacts
CONTACTMarjorie CORNU, MD
PRINCIPAL_INVESTIGATORMarjorie CORNU, MD
University Hospital, Lille
Outcome results
None listed