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NCT Number: NCT05406037

Biomarkers for Invasive Mucormycosis

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).

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Key information

Conditions

Mucorales Infection Bacterial Infections and Mycoses Infections Invasive Fungal Infections Mucormycosis Mycoses Zygomycosis

Age range

3 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Lille

Lille, Hauts-de-France, 59000, France

Location status: Recruiting

Location contact

Marjorie Cornu

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 :
  • 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
  • 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
  • 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

Treatment and study plan

Venous sample

Biological

at Day 0, Day 3, Day 7, Day 14, Day 28 (7 ml blood sample collecting on dry tube) D0 = Diagnostic day

Primary outcomes

  1. Values of the biomarker studied in the patient group versus control groups, expressed as Optical density (OD).

    Time frame: 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 outcomes

  1. Kinetics of the biomarker value measured for hospitalized patients, expressed as Optical density (OD).

    Time frame: 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.

  2. Number of participant with unfavorable clinical evolution (death at D28)

    Time frame: at day 28

    Description of the clinical evolution (death or survival at D28) in parallel with the kinetic of the biomarker value

Study contacts

Contact information is provided by the study sponsor or research team.

Marjorie CORNU, MD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Plateforme PAGés, Analyses Glycoconjugués
  • Région Hauts de France, France
  • SATT Nord

Registry information

Official study title

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

Acronym: BIM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2022
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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