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The study was interrupted prematurely because of the low rate of recruitment.
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EPICA-1 is a multicenter, open label, interventional study which will involve about 30 Internal Medicine Units throughout Italy, enrolling globally at least 100 hospitalised patients with suspicion of invasive candidiasis. These patients will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test: this will allow collection of information on patients outcome. At the same time, patients will be also evaluated by means of blood culture, so that comparison will be possible between the two diagnostic tests (primary end-point of the study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with suspicion of invasive candidiasis | Experimental | Patients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1,3-β-D-glucan quantification | Diagnostic Test | Patients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be evaluated by 1,3-β-D-glucan test and by means of blood culture to confirm the diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the equivalence between two diagnostic test for Candida infections: 1,3-β-D-glucan vs. emocoltura | Will be compared the results of the two diagnostic tests for the same patient's blood sample. In particular will be evaluated if there is accordance between the Candida positivity of an emocolture and the positivity of the 1,3-β-D-glucan test (1,3-β-D-glucan concentrations > 200 pg/ml) for the same patient's blood sample. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of a pre-emptive micafungin treatment on the outcome of patients. | Will be evaluated the mortality (number of dead patients) and ICU transfering (number of patients move to the ICU) reductions | 14 days |
| To describe the trend of 1,3-β-D-glucan in patients during micafungin treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osp. Generale Regionale F. Miulli | Acquaviva delle Fonti | Italy | ||||
| Nuovo Ospedale Civile S. Agostino-Estense |
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|
| Micafungin | Drug | Patients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test. |
|
Will be measured the 1,3-β-D-glucan concentrations in in patients during micafungin treatment |
| 14 days |
| Baggiovara |
| Italy |
| Ospedale di Bussolengo | Bussolengo | Italy |
| Ospedale "S. Anna" | Castelnovo ne' Monti | Italy |
| ASL CN1 Ospedale di Ceva | Ceva | Italy |
| Ospedale Maggiore | Chieri | Italy |
| Ospedale "S. Anna" | Como | Italy |
| Ospedale "S. Biagio" | Domodossola | Italy |
| Ente Ospedaliero Galliera | Genova | Italy |
| Ospedale "Mater Salutis" | Legnago | Italy |
| Ospedale "S.M. Bianca" | Mirandola | Italy |
| Ospedale di Mondovì, | Mondovì | Italy |
| Ospedale "Antonio Cardarelli | Naples | Italy |
| Presidio Ospedaliero S. Maria Delle Grazie | Pozzuoli | Italy |
| Ospedale "G. Fracastoro" | San Bonifacio | Italy |
| Nuovo Ospedale Civile di Sassuolo | Sassuolo | Italy |
| Ospedale Maggiore SS. Annunziata | Savigliano | Italy |
| Ospedale Civile di Sestri Levante | Sestri Levante | Italy |
| Policlinico Borgo Roma | Verona | Italy |
| Ospedale "Magalini | Villafranca di Verona | Italy |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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