Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis (MODIMUCOR)

Centre Hospitalier Universitaire de Besancon

Status

Completed

Conditions

Mucormycosis

Treatments

Other: blood sample

Study type

Interventional

Funder types

Other

Identifiers

NCT02845934

N/2013/65

Details and patient eligibility

About

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.

Full description

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.

Enrollment

248 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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...)