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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Completed
CT.gov ID
NCT02845934
Collaborator
(none)
248
10
1
48
24.8
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: blood sample
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
248 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Jan 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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…)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Universitaire Amiens France
2 Centre Hospitalier Régional Universitaire Besançon France 25030
3 AP-HP_Henri-Mondor Créteil France
4 CHU Dijon France
5 HCL Lyon France
6 CHRU Nancy France
7 CHU Nantes France
8 AP-HP_ Necker Paris France
9 AP-HP_St-Louis Paris France
10 CHU Strasbourg France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT02845934
Other Study ID Numbers:
  • N/2013/65
First Posted:
Jul 27, 2016
Last Update Posted:
Mar 11, 2021
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2021