Prospective Evaluation of a New Molecular Tool for Early Diagnosis of Mucormycosis (MODIMUCOR)
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|ClinicalTrials.gov Identifier: NCT02845934|
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : July 2, 2018
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|
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 (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|
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.
- 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.
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
|Centre Hospitalier Universitaire|
|Centre Hospitalier Régional Universitaire|
|Besançon, France, 25030|