Clinical trial NCT02845934: Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis
Official title: Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mucormycosis
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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...)

Primary outcomes:
measure: test performance
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire
city: Créteil
country: France
facility: AP-HP_Henri-Mondor
city: Dijon
country: France
facility: CHU
city: Lyon
country: France
facility: HCL
city: Nancy
country: France
facility: CHRU
city: Nantes
country: France
facility: CHU
city: Paris
country: France
facility: AP-HP_ Necker
city: Paris
country: France
facility: AP-HP_St-Louis
city: Strasbourg
country: France
facility: CHU
Study officials:
References: