Biomarkers for Invasive Mucormycosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Venous sample.
- Who it may be relevant to
- Registry conditions: Mucorales Infection, Mucormycosis. Basic parameters: 3 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Diagnostic Marker of Mucormycosis : Development and Evaluation of a Diagnostic Assay on a Cohort of Sera
Overview
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
- 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
Primary outcome measures
- Values of the biomarker studied in the patient group versus control groups, expressed as Optical density (OD). [Time frame: at Day 0]
Secondary outcome measures (2)
- 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]
- Number of participant with unfavorable clinical evolution (death at D28) [Time frame: at day 28]
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 :
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- University Hospital of Lille — Lille
Identifiers
NCT: NCT05406037 · 2021_0462 · 2021-A03202-39