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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02845934
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Mucormycosis Other: blood sample Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
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 : January 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. test performance [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845934


Locations
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France
Centre Hospitalier Universitaire
Amiens, France
Centre Hospitalier Régional Universitaire
Besançon, France, 25030
AP-HP_Henri-Mondor
Créteil, France
CHU
Dijon, France
HCL
Lyon, France
CHRU
Nancy, France
CHU
Nantes, France
AP-HP_ Necker
Paris, France
AP-HP_St-Louis
Paris, France
CHU
Strasbourg, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02845934    
Other Study ID Numbers: N/2013/65
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Mucormycosis
Zygomycosis
Mycoses