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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 :
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mucormycosis | Experimental | blood sample |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sample | Other | 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. |
| 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 |
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Inclusion Criteria:
Suspicion of invasive mould infection
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire | Amiens | France | ||||
| Centre Hospitalier Régional Universitaire |
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| ID | Term |
|---|---|
| D009091 | Mucormycosis |
| ID | Term |
|---|---|
| D020096 | Zygomycosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Besançon |
| 25030 |
| France |
| 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 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |