Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis

Study Overview
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Brief Summary
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This Study evaluates the performance (sensitivity, specificity, positive and negative predictive value values and likelihood ratios) of the DNA detection test for the diagnosis of mucormycosis by comparing it to the routine tests such as CT scan aspects, histopathology, microscopy and fungal culture, in a test group of 52 patients including : patients at high-risk according to the EORTC/MSG criteria (patients with prolonged severe neutropenia, receiving corticosteroids or T-cell suppressors, recipients of allogeneic HSCT, or inherited severe immunodeficiency), patients with other predisposing factors of invasive mould disease ( diabetes, AIDS, haematological malignancies or solid tumours, trauma, burns); Patients already diagnosed with probable or proven mucormycosis irrespective of underlying conditions.

Detailed Description
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The patients eligible for this study will already be hospitalized with repeated monitoring of clinical and biological parameters. Participation in the study will result in an additional sampling of blood (estimated volume 6 mL for each sampling) on day of suspicion of the mucormycosis and then twice a week up to a maximum of 8 weeks. vials will be added to the routine sampling of these patients (ie, at the time of routine sampling for galactomannan antigemia), and no new sampling procedure will be required.

Official Title
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Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis

Conditions
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Mucormycosis

Intervention / Treatment
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* Other: blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspicion of invasive mould infection in a patient at high risk according to the EORTC/MSG criteria updated in 2008 (patients with prolonged severe neutropenia, receiving corticosteroids or T-cell suppressor, recipients of allogeneic HSCT, or inherited severe immunodeficiency) or in a patient with other predisposing factors of invasive mould disease ( diabetes, AIDS, haematological malignancies or solid tumours, trauma, burns). Patients already diagnosed with probable or proven mucormycosis irrespective of underlying conditions, including patients referred from other centers. Only adult patients (18 years or older) will be included Exclusion Criteria: Age : under 18 years Patients previously included in the trial with a diagnosis of mucormycosis. However patients previously entered in the trial with a diagnosis other than mucormycosis will be eligible for re- new inclusion. Presence of any medical condition that would not allow collection of blood samples for the qPCR test. History of documented, successfully treated, prior mucormycosis. protected people (pregnant women, minor, guardianship…)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mucormycosis<br>blood sample | Other: blood sample<br>* additional sampling of blood (estimated volume 6 mL for each sampling) on day of suspicion of the mucormycosis and then twice a week up to a maximum of 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| test performance | sensitivity, specificity, positive and negative predictive values and likelihood ratios of the DNA serum detection test will be calculated in probable and proven mucormycosis. | 8 weeks |