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

NCT02845934 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2021-03-11

No results posted yet for this study

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.

Conditions

  • Mucormycosis

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-07-31
Completion
2018-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02845934 on ClinicalTrials.gov