Blood biomarkers to help diagnose invasive mucormycosis

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

This project will test a blood biomarker that looks for unique fungal sugars to see if it can detect invasive mucormycosis in patients with suspected infection, compared with high-risk patients without infection and patients with other fungal infections.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 3 Years to 64 Years
• Sex: All
• Sponsor: University Hospital, Lille (Academic / other)
• Locations: 1 site (Lille, Hauts-de-France)
• Trial ID: NCT05406037 on ClinicalTrials.gov

What this trial studies

This is an observational, hospital-based cohort study using venous blood samples to search for uncommon monosaccharides and oligo/polysaccharides from Mucorales cell walls as potential diagnostic markers. The study enrolls confirmed mucormycosis cases and two control groups: high-risk patients without active infection (pre-transplant assessment) and patients with other invasive fungal infections. Samples will be analyzed in specialized laboratories using biochemical and molecular methods and results compared across groups to determine marker specificity and timing. The goal is to identify whether these cell-wall-derived markers appear reliably in blood early enough to aid clinical decision-making.

Who should consider this trial

Good fit: Ideal participants are patients aged 3–64 with confirmed invasive mucormycosis treated at the University Hospital of Lille, plus control groups of high-risk pre-transplant patients (18–64) without infection and patients with other invasive fungal infections.

Not a fit: People unlikely to benefit include asymptomatic individuals, patients outside the enrolled age ranges, or those with infections not caused by Mucorales.

Why it matters

Potential benefit: If successful, the test could enable earlier and more specific diagnosis of mucormycosis, allowing faster targeted antifungal treatment and potentially lowering mortality.

How similar studies have performed: Biomarker tests like galactomannan or beta-D-glucan are used for other fungal infections, but targeting unique Mucorales cell-wall sugars is relatively novel and not yet widely validated.

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

Where this trial is running

Lille, Hauts-de-France

• University Hospital of Lille — Lille, Hauts-de-France, France (Recruiting)

Study contacts

• Principal investigator: Marjorie CORNU, MD — University Hospital, Lille
• Study coordinator: Marjorie CORNU, MD

Conditions Mucorales Infection; Mucormycosis; Invasive fungal infection; Cell wall oligo/polysaccharides; Biomarkers