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

Not Applicable

Completed

• Conditions: Mucormycosis
• Interventions: Other: blood sample

• Registration Number: NCT02845934
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Primary Completion: 2017-07
• Status Verified: 2017-10
• Study Completion: 2018-01
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mucormycosis	blood sample	blood sample

Primary Outcome Measures

Name	Time	Method
test performance	8 weeks	sensitivity, specificity, positive and negative predictive values and likelihood ratios of the DNA serum detection test will be calculated in probable and proven mucormycosis.

Trial Locations

Locations (8)

Centre Hospitalier Universitaire; 🇫🇷 Amiens, France

Centre Hospitalier Régional Universitaire; 🇫🇷 Besançon, France

CHU; 🇫🇷 Strasbourg, France

HCL; 🇫🇷 Lyon, France

CHRU; 🇫🇷 Nancy, France

AP-HP_ Necker; 🇫🇷 Paris, France

AP-HP_St-Louis; 🇫🇷 Paris, France

AP-HP_Henri-Mondor; 🇫🇷 Créteil, France