Studio multicentrico di confronto fra due test diagnostici (1,3-β-D-glucano vs emocoltura) in pazienti critici con sospetta candidosi invasiva/candidemia degenti presso reparti internistici e in corso di trattamento precoce con echinocandina (micafungina).
The FADOI – EPICA 1 Study
The incidence of invasive candidiasis is constantly increasing and patients hospitalised in Internal Medicine are particularly at risk for Candida infections due to underlying diseases, the large number of devices in situ and other risk factors for invasive fungal infection. The most critical aspect in the management of candidiasis is the timing of treatment: it is well documented that a delay in the beginning of antifungal therapy can significantly increase mortality, also double up if the start of treatment is delayed beyond 12 hours after clinical suspicion. This delay is often due to the most used diagnostic laboratory method (blood culture) which needs at least 3 to 5 days and whose results are not reliable in a not negligible percentage of cases. There is therefore substantial need to improve the management of invasive candidiasis in clinical practice. The search of 1,3-β-D-glucan performed on serum samples (sensitivity 64%, specify 84%) could represent a more rapid diagnostic alternative to confirm or exclude the clinical suspicion of invasive candidiasis. Moreover, since ESCMID Guidelines suggest echinocandins as the first line treatment in critically ill patients with candidemia, it could be useful to evaluate efficacy and safety of an early treatment (without waiting for results from blood culture) with echinocandin in patients hospitalised in Internal Medicine and with suspicion of invasive candidiasis.
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).
Patient enrollment is planned to start in January 2018.
The FADOI - EPICA1 Study
- EPICA 1 – Sinossi 13 10 2017
- EPICA 1 – Protocollo 13 10 2017
- 1_CONCIA_INFEZIONI FUNGINE IN MRD. INT_razionale_studio
- 2_AZZINI_Disegno dello studio
- 6_COTTINI_GCP-SIV meeting
- 7_AURICCHIO_Farmacovigilanza e Materiovigilanza