Health TrialsbyHealthPanel

Biomarkers for Invasive Mucormycosis

ConditionsMucorales InfectionMucormycosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-64
SponsorUniversity Hospital, Lille

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Patients for whom the inclusion criteria are not met

Co-infection mucormycosis/other IFI

Trial population

Patients cared for at the University Hospitals of Lille and Amiens (France)

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Venous sample

    Biological/Vaccine

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

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Patients with MM1 intervention
Group B: High-risk patients without MM (control group 1)1 intervention
Group C: Patients with another IFI (control group 2)1 intervention

Trial outcomes

Primary outcomes

1

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

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).

Time frame
at Day 0

Secondary outcomes

1

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

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.

Time frame
at Day 3, Day 7, Day 14 and Day 28
2

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

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

Time frame
at day 28

Other outcomes

Sponsors and contacts

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University Hospital, Lille

Lead sponsor

Plateforme PAGés, Analyses Glycoconjugués

Collaborator

Région Hauts de France, France

Collaborator

SATT Nord

Collaborator

Source ClinicalTrials.gov
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