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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
14
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
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.
Osp. Generale Regionale F. Miulli
Acquaviva delle Fonti, Italy
Nuovo Ospedale Civile S. Agostino-Estense
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
...and 10 more locations
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.
Time frame: 14 days
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
Time frame: 14 days
To describe the trend of 1,3-β-D-glucan in patients during micafungin treatment
Will be measured the 1,3-β-D-glucan concentrations in in patients during micafungin treatment
Time frame: 14 days
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