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

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.

Study Overview

• Status: Completed
• Conditions: Mucormycosis
• Intervention / Treatment: Other: blood sample

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 Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • Centre Hospitalier Universitaire
  • Besançon, France, 25030
    • Centre Hospitalier Régional Universitaire
  • Créteil, France
    • AP-HP_Henri-Mondor
  • Dijon, France
    • CHU
  • Lyon, France
    • HCL
  • Nancy, France
    • CHRU
  • Nantes, France
    • CHU
  • Paris, France
    • AP-HP_ Necker
  • Paris, France
    • AP-HP_St-Louis
  • Strasbourg, France
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mucormycosis; blood sample	Other: blood sample; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): January 1, 2018

Study Registration Dates

• First Submitted: July 20, 2016
• First Submitted That Met QC Criteria: July 22, 2016
• First Posted (ESTIMATE): July 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Mucormycosis; Zygomycosis
• Other Study ID Numbers: N/2013/65

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO