Clinical trial NCT05406037: Biomarkers for Invasive Mucormycosis
Official title: Diagnostic Marker of Mucormycosis : Development and Evaluation of a Diagnostic Assay on a Cohort of Sera
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mucorales Infection
Mucormycosis
Keywords: Mucormycosis
Invasive fungal infection
Cell wall oligo/polysaccharides
Biomarkers
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Plateforme PAGés, Analyses Glycoconjugués
name: Région Hauts de France, France
name: SATT Nord
First posted: 2022-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients cared for at the University Hospitals of Lille and Amiens (France)

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).


Eligibility criteria: 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

Primary outcomes:
measure: Values of the biomarker studied in the patient group versus control groups, expressed as Optical density (OD).
timeFrame: at Day 0
Secondary outcomes:
measure: Kinetics of the biomarker value measured for hospitalized patients, expressed as Optical density (OD).
timeFrame: at Day 3, Day 7, Day 14 and Day 28
measure: Number of participant with unfavorable clinical evolution (death at D28)
timeFrame: at day 28
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Marjorie CORNU, MD
role: PRINCIPAL_INVESTIGATOR
References: